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

Not Applicable

Completed

• Conditions: Acute Lung Injury
• Interventions: Procedure: noninvasive positive pressure ventilation; Procedure: oxygen therapy

• Registration Number: NCT01581229
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. acute onset;
2. a clinical presentation of respiratory distress;
3. 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%);
4. presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
5. no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of <18 mm Hg.
6. the cause of ALI is consider to be intro-pulmonary.

Exclusion Criteria

1. age <18 yrs;
2. Glasgow Coma Scale < 11;
3. airway or facial injury;
4. pneumothorax or pneumomediastinum;
5. unable to spontaneously clear secretions from the airways;
6. 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;
7. severe ventricular arrhythmia or unstable myocardial ischemia;
8. severe organ dysfunction (Sequential Organ Failure Assessment score > 3);
9. end-stage patients who were expected to survive < 6 months;
10. severe abdominal distension;
11. refusal to receive NPPV;
12. the cause of ALI is consider to be extrapulmonary;
13. unable to cooperate with NPPV application;
14. active upper gastrointestinal bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPPV	noninvasive positive pressure ventilation	-
Control	oxygen therapy	-

Primary Outcome Measures

Name	Time	Method
the numbers of patients who are actually intubated	1 year
numbers of patients who met the intubation criteria	1 year

Secondary Outcome Measures

Name	Time	Method
inhospital mortalities	1 year
intensive care unit mortalities	1 year

Trial Locations

Locations (1)

Beijing Hospital of the Ministry of Health; 🇨🇳 Beijing, Beijing, China