NCT05708287

Brief Summary

High flow nasal cannula (HFNC) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. In this study, the effects of oxygen delivery by HFNC on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Last Updated

February 1, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

December 14, 2022

Last Update Submit

January 23, 2023

Conditions

Keywords

high flow nasal cannulaoxygenationventilationconventional oxygen therapyArterial Blood Gasses

Outcome Measures

Primary Outcomes (2)

  • The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure

    Change in PaO2 in mmHg(Partial pressure of oxygen in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.

    60 minutes

  • The effect of changing flow rates generated by HFNC on ventilation parameters of 28 patients with mild respiratory failure

    Change in PaCO2 in mmHg(Partial pressure of carbon dioxide in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.

    60 minutes

Study Arms (1)

all patients

EXPERIMENTAL
Device: HFNC

Interventions

HFNCDEVICE

The patients with mild hypoxemia, defined as the need for conventional oxygen therapy (COT) using nasal cannula at 4-5 liters per minute (LPM) to maintain O2 Saturation \>90%, were commenced on HFNC therapy

all patients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimal age 18
  • The patient had invasive blood pressure monitoring via an arterial line in situ
  • The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention

You may not qualify if:

  • Shortness of breath
  • Patients regularly using O2 at home
  • No patient consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah medical center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

February 1, 2023

Study Start

August 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 1, 2023

Record last verified: 2022-12

Locations