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Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive positive pressure ventilation (NPPV)
invasive mechanical ventilation
Sponsored by
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring noninvasive positive pressure ventilation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Institute of Respiratory Medicine, Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NPPV

IMV

Arm Description

Use the NPPV to treat moderate ARDS

Use invasive mechanical ventilation in treating the patients allocated to this group.

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
April 20, 2012
Last Updated
November 20, 2018
Sponsor
Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01585922
Brief Title
Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
noninvasive positive pressure ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPPV
Arm Type
Experimental
Arm Description
Use the NPPV to treat moderate ARDS
Arm Title
IMV
Arm Type
Active Comparator
Arm Description
Use invasive mechanical ventilation in treating the patients allocated to this group.
Intervention Type
Procedure
Intervention Name(s)
noninvasive positive pressure ventilation (NPPV)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
invasive mechanical ventilation
Intervention Description
Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute onset a clinical presentation of respiratory distress 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 presence of bilateral pulmonary infiltrate on chest radiograph no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure( PAWP) < 18 mmHg Exclusion Criteria: age > 70 years or < 18 years PaCO2 > 50mmHg Glasgow Coma Scale (GCS)< 11 Upper airway/facial deformity or injury pneumothorax or pneumomediastinum unable to spontaneously clear secretions from their airway respiratory arrest severe ventricular arrhythmia or active myocardial ischemia severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score > 1) severe chronic lung diseases(COPD, Asthma or ILD, et al) end-stage patients who are expected to survive less than six months severe abdominal distension refuse to receive NPPV unable to cooperate with NPPV
Facility Information:
Facility Name
Beijing Institute of Respiratory Medicine, Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25112957
Citation
Sun B, He H, Wang Z, Qu J, Li X, Ban C, Wan J, Cao B, Tong Z, Wang C. Emergent severe acute respiratory distress syndrome caused by adenovirus type 55 in immunocompetent adults in 2013: a prospective observational study. Crit Care. 2014 Aug 12;18(4):456. doi: 10.1186/s13054-014-0456-6.
Results Reference
derived

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Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

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