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Completed

NCT Number: NCT04568655

The Noninvasive Ventilation to COVID-19 Patients

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,

9)burns, 10) extreme obesity.

Treatment and study plan

Noninvasive Ventilation

Device

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

Primary outcomes

  1. success rate

    Time frame: 4 month

    the sucess rate of the noninvasive ventilation

  2. the intubtion rate

    Time frame: 4 month

    the intubtion rate of the COVID-19 patients

Secondary outcomes

  1. blood lymphocyte

    Time frame: 4month

    blood lymphocyte of the COVID-19 patients

  2. B-type natriuretic peptide

    Time frame: 4 month

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

  3. Procalcitonin

    Time frame: 4 month

    blood procalcitonin of the COVID-19 patients

  4. Oxygen Saturation

    Time frame: 4 month

    Oxygen Saturation of the COVID-19 patients

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

The Noninvasive Ventilation to COVID-19 Patients With Respiratory Failure

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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