Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury

Beijing Hospital1 site in 1 country204 target enrollmentJune 2012

ConditionsAcute Lung Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Lung Injury
Sponsor: Beijing Hospital
Enrollment: 204
Locations: 1
Primary Endpoint: the numbers of patients who are actually intubated
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration oxygen therapy.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

December 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Hospital

Responsible Party

Principal Investigator

Chen Wang

vice president

Beijing Hospital

Eligibility Criteria

Inclusion Criteria

•acute onset;
•a clinical presentation of respiratory distress;
•arterial oxygen tension/inspired oxygen fraction (PaO2/FIO2) \< 300 mmHg but \> 200 mmHg while breathing oxygen delivered by a conventional Venturi device at a maximum concentration (50%);
•presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
•no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of \<18 mm Hg.
•the cause of ALI is consider to be intro-pulmonary.

Exclusion Criteria

•age \<18 yrs;
•Glasgow Coma Scale \< 11;
•airway or facial injury;
•pneumothorax or pneumomediastinum;
•unable to spontaneously clear secretions from the airways;
•cardiogenic shock or severe hemodynamic instability (systolic blood pressure \<90 mmHg associated with decreased urinary output (\<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes;
•severe ventricular arrhythmia or unstable myocardial ischemia;
•severe organ dysfunction (Sequential Organ Failure Assessment score \> 3);
•end-stage patients who were expected to survive \< 6 months;
•severe abdominal distension;