Noninvasive Positive Pressure Ventilation in Moderate Acute Respiratory Distress Syndrome

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Institute of Respiratory Medicine, Beijing Hospital

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

noninvasive positive pressure ventilation (NPPV)

Procedure

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.

Invasive mechanical ventilation

Procedure

Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Apr 26, 2012
Registry last updated: Nov 21, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed