NCT00343993

Brief Summary

with appropriate inspired oxygen concentrations, NPPV would prevent intubation and hence avert the poor outcome associated with the need of invasive ventilation in patients with ALI/ARDS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2007

First QC Date

June 23, 2006

Last Update Submit

April 3, 2007

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

noninvasive positive pressure ventilationacute lung injuryacute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

  • The intubation rate who meet the intubation criteria predefined

Secondary Outcomes (1)

  • Mortality in the ICU and hospital

Interventions

noninvasive positive pressure ventilationDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the ALI/ARDS criteria

You may not qualify if:

  • Age \> 85
  • pH \< 7.35 or PaCO2 \>50mmHg
  • Glasgow Coma Scale (GCS)\<11
  • Airway or facial deformity
  • Pneumothorax or pneumomediastinum
  • Unable to spontaneously clear secretions from their airway
  • Respiratory arrest
  • Shock or 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 active myocardial ischemia
  • Severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, SOFA score\>1)
  • End-stage patients who are expected to survive less than six months
  • Severe abdominal distension
  • Refuse to receive NPPV
  • Unable to cooperate with the application of NPPV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing chaoyang hospital-affiliate of capital medical university

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Wang Chen, MD

    Beijing Chao Yang Hospital

    STUDY CHAIR

Central Study Contacts

Zhan Q Yuan, MD

CONTACT

86-10-85231543ards@vip.163.com

Sun Bin, MD

CONTACT

86-0-13911151075ards@vip.163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2007

Last Updated

April 4, 2007

Record last verified: 2007-04

Locations

CN(1)