Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

November 20, 2018 updated by: Chen Wang, Beijing Hospital
In order to identify the effect of noninvasive positive pressure ventilation (NPPV) on decreasing inflammatory response, improving the pathophysiological manifestation and reducing the morbidity and mortality in the moderate acute respiratory distress syndrome (ARDS) patients, the investigators conduct this clinical trial comparing NPPV with invasive mechanical ventilation in more than twenty ICUs in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Beijing Institute of Respiratory Medicine, Beijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. acute onset
  2. a clinical presentation of respiratory distress
  3. arterial oxygen tension/inspired oxygen fraction (PaO2/FiO2) between 200 mmHg to 300 mmHg. The arterial oxygen tension will be measured in fifteen minutes after NPPV (CPAP 5 cmH2O) was used to the patients stably
  4. presence of bilateral pulmonary infiltrate on chest radiograph
  5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg

Exclusion Criteria:

  1. age > 70 years or < 18 years
  2. PaCO2 > 50mmHg
  3. Glasgow Coma Scale (GCS)< 11
  4. Upper airway/facial deformity or injury
  5. pneumothorax or pneumomediastinum
  6. unable to spontaneously clear secretions from their airway
  7. respiratory arrest
  8. severe ventricular arrhythmia or active myocardial ischemia
  9. severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1)
  10. severe chronic lung diseases(COPD, Asthma or ILD, et al)
  11. end-stage patients who are expected to survive less than six months
  12. severe abdominal distension
  13. refuse to receive NPPV
  14. unable to cooperate with NPPV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPPV
Use the NPPV to treat moderate ARDS
Procedure: noninvasive positive pressure ventilation (NPPV)
Use NPPV to treat the ARDS patients,and we choose the NPPV ventilators in which the FiO2 can be fixed, for example: the BiPAP Vision or V60 of Phillip Respironics.
Active Comparator: IMV
Use invasive mechanical ventilation in treating the patients allocated to this group.
Procedure: invasive mechanical ventilation
Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days
From the date of randomization to the date of discharge from ICU and hospital, or to the date of death of all cause, an expected average of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120418BIRM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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