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CompletedNCT04568655Updated Sep 29, 2020

The Noninvasive Ventilation to COVID-19 Patients

An observational study in Noninvavie Ventilation to Patients With COVID-19, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
23
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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.We wish to raise the success rate to COVID-19 patients with respiratory failure.More critically ill COVID-19 patients could avoid the intubtion.

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Conditions studied

  • Noninvavie Ventilation to Patients With COVID-19

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Keywords

  • noninvavie ventilation
  • COVID-19
  • respiratory failure
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 23 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

respiratory failure patients with COVID-19

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Severe cardiovascular disease,
  2. respiratory arrest,
  3. cardiovascular instability (hypotension, arrhythmias, myocardial infarction),
  4. change in mental status or patients who were uncooperative, high risk of aspiration, viscous or copious
  5. secretions,
  6. recent facial or gastroesophageal surgery,
  7. craniofacial trauma, 8)fixed nasopharyngeal abnormalities,

9)burns, 10) extreme obesity.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID-19 patients need noninvasive ventilation

    Device: noninvasive ventilation

Interventions

  • Devicenoninvasive ventilation

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

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What researchers measure

Primary outcomes

  1. success rate

    the sucess rate of the noninvasive ventilation

    Time frame: 4 month

  2. the intubtion rate

    the intubtion rate of the COVID-19 patients

    Time frame: 4 month

Secondary outcomes

  1. blood lymphocyte

    blood lymphocyte of the COVID-19 patients

    Time frame: 4month

  2. B-type natriuretic peptide

    blood B-type natriuretic peptide of the COVID-19 patients

    Time frame: 4 month

  3. Procalcitonin

    blood procalcitonin of the COVID-19 patients

    Time frame: 4 month

  4. Oxygen Saturation

    Oxygen Saturation of the COVID-19 patients

    Time frame: 4 month

07

Study locations

1 site
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 520120, China
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References and documents

Individual participant data

Plan to share: Undecided — the IPD are going to share after the paper published.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04568655
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Zhang Jianheng (The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Sep 29, 2020
Start date
Feb 1, 2020
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Sep 29, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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