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

Study Overview
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Brief Summary
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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.

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Procedure: noninvasive positive pressure ventilation
* Procedure: oxygen therapy


Participation Criteria
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Eligibility Criteria
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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; refusal to receive NPPV; the cause of ALI is consider to be extrapulmonary; unable to cooperate with NPPV application; active upper gastrointestinal bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPPV<br> | Procedure: noninvasive positive pressure ventilation<br>* Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.<br>|
| Active Comparator: Control<br> | Procedure: oxygen therapy<br>* In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of patients who met the intubation criteria |  | 1 year | 
| the numbers of patients who are actually intubated |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhospital mortalities |  | 1 year | 
| intensive care unit mortalities |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALI;noninvasive positive pressure ventilation