NCT01581229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

4.5 years

First QC Date

April 18, 2012

Last Update Submit

November 20, 2018

Conditions

Acute Lung Injury

Keywords

ALI;noninvasive positive pressure ventilation

Outcome Measures

Primary Outcomes (2)

  • numbers of patients who met the intubation criteria

    1 year

  • the numbers of patients who are actually intubated

    1 year

Secondary Outcomes (2)

  • inhospital mortalities

    1 year

  • intensive care unit mortalities

    1 year

Study Arms (2)

NPPV

EXPERIMENTAL
Procedure: noninvasive positive pressure ventilation

Control

ACTIVE COMPARATOR
Procedure: oxygen therapy

Interventions

noninvasive positive pressure ventilationPROCEDURE

Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.

NPPV
oxygen therapyPROCEDURE

In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hospital of the Ministry of Health

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • 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.

    PMID: 31484582DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Chen Wang, MD, PHD

    Beijing Hospital of the Ministry of Health; Beijing Institute of Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 20, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

CN(1)