Brief Summary

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

243

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2023

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

September 19, 2022

Completed

5 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed

26 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed

Last Updated

March 27, 2023

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

September 19, 2022

Last Update Submit

March 13, 2023

Conditions

Hypoxemia

Keywords

Hypoxemia, High-flow nasal cannula, Mechanical ventilation

Outcome Measures

Primary Outcomes (334)

HR
Heart rate
At the time of enrollment in the clinical study
HR
Heart rate
On the first hour after enrollment
HR
Heart rate
On the second hour after enrollment
HR
Heart rate
On the 6th hour after enrollment
HR
Heart rate
On the 12th hour after enrollment
HR
Heart rate
On the 24th hour after enrollment
HR
Heart rate
On the 25th hour after enrollment (On the first hour after crossover)
HR
Heart rate
On the 26th hour after enrollment (On the second hour after crossover)
HR
Heart rate
On the 30th hour after enrollment (On the 6th hour after crossover)
HR
Heart rate
On the 36th hour after enrollment (On the 12th hour after crossover)
HR
Heart rate
On the 48th hour after enrollment (On the 24th hour after crossover)
HR
Heart rate
On the third day after enrollment (On the 48th hour after crossover)
HR
Heart rate
On the 4th day after enrollment (On the third day after crossover)
HR
Heart rate
On the 5th day after enrollment (On the 4th day after crossover)
HR
Heart rate
On the 6th day after enrollment (On the 5th day after crossover)
HR
Heart rate
On the 7th day after enrollment (On the 6th day after crossover)
HR
Heart rate
On the 8th day after enrollment (On the 7th day after crossover)
HR
Heart rate
On the 9th day after enrollment (On the 8th day after crossover)
RR
Respiratory rate
At the time of enrollment in the clinical study
RR
Respiratory rate
On the first hour after enrollment
RR
Respiratory rate
On the second hour after enrollment
RR
Respiratory rate
On the 6th hour after enrollment
RR
Respiratory rate
On the 12th hour after enrollment
RR
Respiratory rate
On the 24th hour after enrollment
RR
Respiratory rate
On the 25th hour after enrollment (On the first hour after crossover)
RR
Respiratory rate
On the 26th hour after enrollment (On the second hour after crossover)
RR
Respiratory rate
On the 30th hour after enrollment (On the 6th hour after crossover)
RR
Respiratory rate
On the 36th hour after enrollment (On the 12th hour after crossover)
RR
Respiratory rate
On the 48th hour after enrollment (On the 24th hour after crossover)
RR
Respiratory rate
On the third day after enrollment (On the 48th hour after crossover)
RR
Respiratory rate
On the 4th day after enrollment (On the third day after crossover)
RR
Respiratory rate
On the 5th day after enrollment (On the 4th day after crossover)
RR
Respiratory rate
On the 6th day after enrollment (On the 5th day after crossover)
RR
Respiratory rate
On the 7th day after enrollment (On the 6th day after crossover)
RR
Respiratory rate
On the 8th day after enrollment (On the 7th day after crossover)
RR
Respiratory rate
On the 9th day after enrollment (On the 8th day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
At the time of enrollment in the clinical study
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the first hour after enrollment
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the second hour after enrollment
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 6th hour after enrollment
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 12th hour after enrollment
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 24th hour after enrollment
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 25th hour after enrollment (On the first hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 26th hour after enrollment (On the second hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 30th hour after enrollment (On the 6th hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 36th hour after enrollment (On the 12th hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 48th hour after enrollment (On the 24th hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the third day after enrollment (On the 48th hour after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 4th day after enrollment (On the third day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 5th day after enrollment (On the 4th day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 6th day after enrollment (On the 5th day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 7th day after enrollment (On the 6th day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 8th day after enrollment (On the 7th day after crossover)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
On the 9th day after enrollment (On the 8th day after crossover)
SO2
Pulse oxygen saturation
At the time of enrollment in the clinical study
SO2
Pulse oxygen saturation
On the first hour after enrollment
SO2
Pulse oxygen saturation
On the second hour after enrollment
SO2
Pulse oxygen saturation
On the 6th hour after enrollment
SO2
Pulse oxygen saturation
On the 12th hour after enrollment
SO2
Pulse oxygen saturation
On the 24th hour after enrollment
SO2
Pulse oxygen saturation
On the 25th hour after enrollment (On the first hour after crossover)
SO2
Pulse oxygen saturation
On the 26th hour after enrollment (On the second hour after crossover)
SO2
Pulse oxygen saturation
On the 30th hour after enrollment (On the 6th hour after crossover)
SO2
Pulse oxygen saturation
On the 36th hour after enrollment (On the 12th hour after crossover)
SO2
Pulse oxygen saturation
On the 48th hour after enrollment (On the 24th hour after crossover)
SO2
Pulse oxygen saturation
On the third day after enrollment (On the 48th hour after crossover)
SO2
Pulse oxygen saturation
On the 4th day after enrollment (On the third day after crossover)
SO2
Pulse oxygen saturation
On the 5th day after enrollment (On the 4th day after crossover)
SO2
Pulse oxygen saturation
On the 6th day after enrollment (On the 5th day after crossover)
SO2
Pulse oxygen saturation
On the 7th day after enrollment (On the 6th day after crossover)
SO2
Pulse oxygen saturation
On the 8th day after enrollment (On the 7th day after crossover)
SO2
Pulse oxygen saturation
On the 9th day after enrollment (On the 8th day after crossover)
pH
Degree of pH in arterial blood
At the time of enrollment in the clinical study
pH
Degree of pH in arterial blood
On the 24th hour after enrollment
pH
Degree of pH in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
pH
Degree of pH in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
pH
Degree of pH in arterial blood
On the 4th day after enrollment (On the 3th day after crossover)
pH
Degree of pH in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
pH
Degree of pH in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
pH
Degree of pH in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
pH
Degree of pH in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
pH
Degree of pH in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
PaO2
Partial arterial oxygen pressure
At the time of enrollment in the clinical study
PaO2
Partial arterial oxygen pressure
On the 24th hour after enrollment
PaO2
Partial arterial oxygen pressure
On the 48th hour after enrollment (On the 24th hour after crossover)
PaO2
Partial arterial oxygen pressure
On the third day after enrollment (On the 48th hour after crossover)
PaO2
Partial arterial oxygen pressure
On the 4th day after enrollment (On the 3th day after crossover)
PaO2
Partial arterial oxygen pressure
On the 5th day after enrollment (On the 4th day after crossover)
PaO2
Partial arterial oxygen pressure
On the 6th day after enrollment (On the 5th day after crossover)
PaO2
Partial arterial oxygen pressure
On the 7th day after enrollment (On the 6th day after crossover)
PaO2
Partial arterial oxygen pressure
On the 8th day after enrollment (On the 7th day after crossover)
PaO2
Partial arterial oxygen pressure
On the 9th day after enrollment (On the 8th day after crossover)
SaO2
Arterial oxygen saturation
At the time of enrollment in the clinical study
SaO2
Arterial oxygen saturation
On the 24th hour after enrollment
SaO2
Arterial oxygen saturation
On the 48th hour after enrollment (On the 24th hour after crossover)
SaO2
Arterial oxygen saturation
On the third day after enrollment (On the 48th hour after crossover)
SaO2
Arterial oxygen saturation
On the 4th day after enrollment (On the third day after crossover)
SaO2
Arterial oxygen saturation
On the 5th day after enrollment (On the 4th day after crossover)
SaO2
Arterial oxygen saturation
On the 6th day after enrollment (On the 5th day after crossover)
SaO2
Arterial oxygen saturation
On the 7th day after enrollment (On the 6th day after crossover)
SaO2
Arterial oxygen saturation
On the 8th day after enrollment (On the 7th day after crossover)
SaO2
Arterial oxygen saturation
On the 9th day after enrollment (On the 8th day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
At the time of enrollment in the clinical study
PCO2
partial pressure of carbon dioxide in arterial blood
On the 24th hour after enrollment
PCO2
partial pressure of carbon dioxide in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 4th day after enrollment (On the third day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
PCO2
partial pressure of carbon dioxide in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
FiO2
Fraction of inspiration O2
At the time of enrollment in the clinical study
FiO2
Fraction of inspiration O2
On the 24th hour after enrollment
FiO2
Fraction of inspiration O2
On the 48th hour after enrollment (On the 24th hour after crossover)
FiO2
Fraction of inspiration O2
On the third day after enrollment (On the 48th hour after crossover)
FiO2
Fraction of inspiration O2
On the 4th day after enrollment (On the third day after crossover)
FiO2
Fraction of inspiration O2
On the 5th day after enrollment (On the 4th day after crossover)
FiO2
Fraction of inspiration O2
On the 6th day after enrollment (On the 5th day after crossover)
FiO2
Fraction of inspiration O2
On the 7th day after enrollment (On the 6th day after crossover)
FiO2
Fraction of inspiration O2
On the 8th day after enrollment (On the 7th day after crossover)
FiO2
Fraction of inspiration O2
On the 9th day after enrollment (On the 8th day after crossover)
Lac
Lactic acid in arterial blood
At the time of enrollment in the clinical study
Lac
Lactic acid in arterial blood
On the 24th hour after enrollment
Lac
Lactic acid in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
Lac
Lactic acid in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
Lac
Lactic acid in arterial blood
On the 4th day after enrollment (On the third day after crossover)
Lac
Lactic acid in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
Lac
Lactic acid in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
Lac
Lactic acid in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
Lac
Lactic acid in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
Lac
Lactic acid in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
Glu
Arterial blood glucose in arterial blood
At the time of enrollment in the clinical study
Glu
Arterial blood glucose in arterial blood
On the 24th hour after enrollment
Glu
Arterial blood glucose in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
Glu
Arterial blood glucose in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
GLu
Arterial blood glucose in arterial blood
On the 4th day after enrollment (On the third day after crossover)
Glu
Arterial blood glucose in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
Glu
Arterial blood glucose in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
Glu
Arterial blood glucose in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
Glu
Arterial blood glucose in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
Glu
Arterial blood glucose in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
At the time of enrollment in the clinical study
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 24th hour after enrollment
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the third day after enrollment (On the 48th hour after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 4th day after enrollment (On the third day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
BE
Base excess in arterial blood
At the time of enrollment in the clinical study
BE
Base excess in arterial blood
On the 24th hour after enrollment
BE
Base excess in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
BE
Base excess in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
BE
Base excess in arterial blood
On the 4th day after enrollment (On the third day after crossover)
BE
Base excess in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
BE
Base excess in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
BE
Base excess in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
BE
Base excess in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
BE
Base excess in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
RI
Respiratory Index
At the time of enrollment in the clinical study
RI
Respiratory Index
On the 24th hour after enrollment
RI
Respiratory Index
On the 48th hour after enrollment (On the 24th hour after crossover)
RI
Respiratory Index
On the third day after enrollment (On the 48th hour after crossover)
RI
Respiratory Index
On the 4th day after enrollment (On the third day after crossover)
RI
Respiratory Index
On the 5th day after enrollment (On the 4th day after crossover)
RI
Respiratory Index
On the 6th day after enrollment (On the 5th day after crossover)
RI
Respiratory Index
On the 7th day after enrollment (On the 6th day after crossover)
RI
Respiratory Index
On the 8th day after enrollment (On the 7th day after crossover)
RI
Respiratory Index
On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
At the time of enrollment in the clinical study
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 24th hour after enrollment
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the third day after enrollment (On the 48th hour after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 4th day after enrollment (On the third day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
At the time of enrollment in the clinical study
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 24th hour after enrollment
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the third day after enrollment (On the 48th hour after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 4th day after enrollment (On the third day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood K+ concentration
Arterial blood K+ concentration
On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
At the time of enrollment in the clinical study
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 24th hour after enrollment
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the third day after enrollment (On the 48th hour after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 4th day after enrollment (On the third day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
At the time of enrollment in the clinical study
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 24th hour after enrollment
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the third day after enrollment (On the 48th hour after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 4th day after enrollment (On the third day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood Na+ concentration
Arterial blood Na+ concentration
On the 9th day after enrollment (On the 8th day after crossover)
TCO2
Total carbon dioxide in arterial blood
At the time of enrollment in the clinical study
TCO2
Total carbon dioxide in arterial blood
On the 24th hour after enrollment
TCO2
Total carbon dioxide in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
TCO2
Total carbon dioxide in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 4th day after enrollment (On the third day after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
TCO2
Total carbon dioxide in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
HCT
hematocrit in arterial blood
At the time of enrollment in the clinical study
HCT
hematocrit in arterial blood
On the 24th hour after enrollment
HCT
hematocrit in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
HCT
hematocrit in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
HCT
hematocrit in arterial blood
On the 4th day after enrollment (On the third day after crossover)
HCT
hematocrit in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
HCT
hematocrit in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
HCT
hematocrit in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
HCT
hematocrit in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
HCT
hematocrit in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
tHbc
Total hemoglobin in arterial blood
At the time of enrollment in the clinical study
tHbc
Total hemoglobin in arterial blood
On the 24th hour after enrollment
tHbc
Total hemoglobin in arterial blood
On the 48th hour after enrollment (On the 24th hour after crossover)
tHbc
Total hemoglobin in arterial blood
On the third day after enrollment (On the 48th hour after crossover)
tHbc
Total hemoglobin in arterial blood
On the 4th day after enrollment (On the third day after crossover)
tHbc
Total hemoglobin in arterial blood
On the 5th day after enrollment (On the 4th day after crossover)
tHbc
Total hemoglobin in arterial blood
On the 6th day after enrollment (On the 5th day after crossover)
tHbc
Total hemoglobin in arterial blood
On the 7th day after enrollment (On the 6th day after crossover)
tHbc
Total hemoglobin in arterial blood
On the 8th day after enrollment (On the 7th day after crossover)
tHbc
Total hemoglobin in arterial blood
On the 9th day after enrollment (On the 8th day after crossover)
height
m
At the time of enrollment in the clinical study
Weight
Kg
At the time of enrollment in the clinical study
gender
Male and female
At the time of enrollment in the clinical study
age
year
At the time of enrollment in the clinical study
WBC
The number of white blood cells in venous blood
On the first day after enrollment
WBC
The number of white blood cells in venous blood
up to 9 days
NEU
The number of Neutrophil granulocyte in venous blood
On the first day after enrollment
NEU
The number of Neutrophil granulocyte in venous blood
up to 9 days
LYM
The number of Venous blood lymphocytes in venous blood
On the first day after enrollment
LYM
The number of Venous blood lymphocytes in venous blood
up to 9 days
EOS
The number of Venous blood eosinophils in venous blood
On the first day after enrollment
EOS
The number of Venous blood eosinophils in venous blood
up to 9 days
BAS
The number of Venous blood Basophils in venous blood
On the first day after enrollment
BAS
The number of Venous blood Basophils in venous blood
up to 9 days
MON
The number of Venous blood Monocyte cell in venous blood
On the first day after enrollment
MON
The number of Venous blood Monocyte cell in venous blood
up to 9 days
RBC
The number of red blood cells in venous blood
On the first day after enrollment
RBC
The number of red blood cells in venous blood
up to 9 days
HGB
The number of haemoglobin in venous blood
On the first day after enrollment
HGB
The number of haemoglobin in venous blood
up to 9 days
HCT
hematocrit in venous blood
On the first day after enrollment
HCT
hematocrit in venous blood
up to 9 days
MCV
Mean Corpuscular Volume in venous blood
On the first day after enrollment
MCV
Mean Corpuscular Volume in venous blood
up to 9 days
MCH
Mean Corpuscular Haemoglobin Concentration in venous blood
On the first day after enrollment
MCH
Mean Corpuscular Haemoglobin Concentration in venous blood
up to 9 days
RDW
red blood cell distribution width in venous blood
On the first day after enrollment
RDW
red blood cell distribution width in venous blood
up to 9 days
PLT
platelet in venous blood
On the first day after enrollment
PLT
platelet in venous blood
up to 9 days
PDW
Platelet distributionwidth in venous blood
On the first day after enrollment
PDW
Platelet distributionwidth in venous blood
up to 9 days
MPV
Mean Platelet Volume in venous blood
On the first day after enrollment
MPV
Mean Platelet Volume in venous blood
up to 9 days
plateletcrit
plateletcrit in venous blood
On the first day after enrollment
plateletcrit
plateletcrit in venous blood
up to 9 days
CRP
C-reactive protein in venous blood
On the first day after enrollment
CRP
C-reactive protein in venous blood
up to 9 days
PCT
Procalcitonin in venous blood
On the first day after enrollment
PCT
Procalcitonin in venous blood
up to 9 days
NT-proBNP
NT-proBNP in venous blood
On the first day after enrollment
NT-proBNP
NT-proBNP in venous blood
up to 9 days
ESR
erythrocytesedimentationrate in venous blood
On the first day after enrollment
ESR
erythrocytesedimentationrate in venous blood
up to 9 days
PT
prothrombin time in venous blood
On the first day after enrollment
PT
prothrombin time in venous blood
up to 9 days
APTT
activated partial thromboplastin time in venous blood
On the first day after enrollment
APTT
activated partial thromboplastin time in venous blood
up to 9 days
TT
Thrombin time in venous blood
On the first day after enrollment
TT
Thrombin time in venous blood
up to 9 days
D-Di
D-Dimer in venous blood
On the first day after enrollment
D-Di
D-Dimer in venous blood
up to 9 days
ALT
alanine transaminase in venous blood
On the first day after enrollment
ALT
alanine transaminase in venous blood
up to 9 days
AST
Aspartate Transaminase in venous blood
On the first day after enrollment
AST
Aspartate Transaminase in venous blood
up to 9 days
PA
Serum prealbumin in venous blood
On the first day after enrollment
PA
Serum prealbumin in venous blood
up to 9 days
TP
Total serum protein in venous blood
On the first day after enrollment
TP
Total serum protein in venous blood
up to 9 days
ALB
Albumin protein in venous blood
On the first day after enrollment
ALB
Albumin protein in venous blood
up to 9 days
GLB
Globulin globulin in venous blood
On the first day after enrollment
GLB
Globulin globulin in venous blood
up to 9 days
Cr
creatinine in venous blood
On the first day after enrollment
Cr
creatinine in venous blood
up to 9 days
BUN
Urea nitrogen in venous blood
On the first day after enrollment
BUN
Urea nitrogen in venous blood
up to 9 days
Cys-C
Cystatin C in venous blood
On the first day after enrollment
Cys-C
Cystatin C in venous blood
up to 9 days
eGFR
Estimate glomerular filtration rate in venous blood
On the first day after enrollment
eGFR
Estimate glomerular filtration rate in venous blood
up to 9 days
Respiratory support time
Daily respiratory support time after patients were enrolled in the clinical study，h/Day
during hospitalization, approximately 9 days
Relief time for dyspnea
Remission time of dyspnea after intervention
during hospitalization, approximately 9 days
Tracheal intubation
Yes or No
during hospitalization, approximately 9 days
Stay in the ICU
Yes or No
during hospitalization, approximately 9 days
Complications
Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure.
during hospitalization, approximately 9 days
Outcome of disease
Get better, get worse, die
during hospitalization, approximately 9 days
Total bilirubin
Serum total bilirubin in venous blood
On the first day after enrollment
Total bilirubin
Serum total bilirubin in venous blood
up to 9 days
DBIL
Direct bilirubin in venous blood
On the first day after enrollment
DBIL
Direct bilirubin in venous blood
up to 9 days
IBIL
Indirect bilirubin in venous blood
On the first day after enrollment
IBIL
Indirect bilirubin in venous blood
up to 9 days
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
At the time of enrollment in the clinical study
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
On the 24th hour after enrollment
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
On the 48th hour after enrollment (On the 24th hour after crossover)
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
up to 9 days
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
At the time of enrollment in the clinical study
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
On the 24th hour after enrollment
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
On the 48th hour after enrollment (On the 24th hour after crossover)
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
up to 9 days

Secondary Outcomes (3)

Patient compliance to the treatment
during hospitalization, approximately 9 days
Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort
during hospitalization, approximately 9 days
Dyspnea rating scale
during hospitalization, approximately 9 days

Study Arms (2)

Non-invasive BiPAP ventilation treatment group

EXPERIMENTAL

Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2\>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge

Device: Non-invasive BiPAP ventilationDevice: HFNC

HFNC treatment group

EXPERIMENTAL

On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.

Device: Non-invasive BiPAP ventilationDevice: HFNC

Interventions

Non-invasive BiPAP ventilationDEVICE

Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2\>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.

Also known as: HFNC

HFNC treatment groupNon-invasive BiPAP ventilation treatment group

HFNCDEVICE

Also known as: Non-invasive BiPAP ventilation

HFNC treatment groupNon-invasive BiPAP ventilation treatment group

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

PaO2 \< 60mmHg, SpO2 \< 92%(without oxygen inhalation);
Mild to moderate type I respiratory failure (100 mmHg \< PaO/Fi02≤300 mmHg);

You may not qualify if:

Missing primary outcome measures
Terminal stage of various chronic diseases;
The patient or family members do not agree to NIV or HFNI treatment;
Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
Ventilation dysfunction (pH\<7.30)
Contradictory breathing
The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
Serious diseases, such as organ function damage and sepsis;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Qilu Hospital of Shandong Universitylead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (3)

Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
PMID: 28124736RESULT
Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
PMID: 33661521RESULT
Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese.
PMID: 29886648RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Dedong Ma, MD
Qilu Hospital of Shandong University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Dedong Ma, MD

CONTACT

18560082806 ma@qiluhuxi.com

chunwei He, master

CONTACT

17361616499 hechw160814@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

March 27, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 6, 2024

Last Updated

March 27, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (334)

Secondary Outcomes (3)

Study Arms (2)

Non-invasive BiPAP ventilation treatment group

HFNC treatment group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations