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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury
• Intervention / Treatment: Procedure: noninvasive positive pressure ventilation; Procedure: oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Hospital of the Ministry of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
inhospital mortalities	1 year
intensive care unit mortalities	1 year

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Principal Investigator: Chen Wang, MD, PHD, Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine

Publications and helpful links

General Publications

• He H, Sun B, Liang L, Li Y, Wang H, Wei L, Li G, Guo S, Duan J, Li Y, Zhou Y, Chen Y, Li H, Yang J, Xu X, Song L, Chen J, Bao Y, Chen F, Wang P, Ji L, Zhang Y, Ding Y, Chen L, Wang Y, Yang L, Yang T, Weng H, Li H, Wang D, Tong J, Sun Y, Li R, Jin F, Li C, He B, Sun L, Wang C, Hu M, Yang X, Luo Q, Zhang J, Tan H, Wang C; ENIVA Study Group. A multicenter RCT of noninvasive ventilation in pneumonia-induced early mild acute respiratory distress syndrome. Crit Care. 2019 Sep 4;23(1):300. doi: 10.1186/s13054-019-2575-6.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: ALI;noninvasive positive pressure ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 2012BAI05B00