NCT04568655

Brief Summary

Noninvasive ventilation(NIV) is an important treatment to the respiratory failure patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory failure.The NIV may reduce the intubtion rate.This research was taken to investigate the factor to the success of the noninvasive ventilation to the COVID-19 patients with respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

September 28, 2020

Last Update Submit

September 28, 2020

Conditions

Keywords

noninvavie ventilationCOVID-19respiratory failure

Outcome Measures

Primary Outcomes (2)

  • success rate

    the sucess rate of the noninvasive ventilation

    4 month

  • the intubtion rate

    the intubtion rate of the COVID-19 patients

    4 month

Secondary Outcomes (4)

  • blood lymphocyte

    4month

  • B-type natriuretic peptide

    4 month

  • Procalcitonin

    4 month

  • Oxygen Saturation

    4 month

Study Arms (1)

COVID-19 patients need noninvasive ventilation

Device: noninvasive ventilation

Interventions

noninvasive ventilation to support the COVID-19 patients with respiratory failure

COVID-19 patients need noninvasive ventilation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

respiratory failure patients with COVID-19

You may qualify if:

  • Shortness of breath, RR\>30 times per minute;
  • At room air, SpO2 lower than 93%;
  • The partial pressure of Arterial blood oxygen (PaO2)/the fraction of inspired oxygen (FiO2) ≤ 300mmHg;
  • CT(computed tomography) chest imaging shows that lung damage develops significantly within 24 to 48 hours.

You may not qualify if:

  • Severe cardiovascular disease,
  • respiratory arrest,
  • cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
  • change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
  • secretions,
  • recent facial or gastroesophageal surgery,
  • craniofacial trauma, 8)fixed nasopharyngeal abnormalities,
  • )burns, 10) extreme obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

Location

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

First Submitted

September 28, 2020

First Posted

September 29, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations