MedDataX Logo

Noninvasive Positive Pressure Ventilation for ALI/ARDS:a Multicentre Randomized Controlled Trial

NCT ID: NCT00343993

Last Updated: 2007-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of patients suffering acute respiratory failure. High-level evidence supports the use of NPPV to treat exacerbation of chronic obstructive pulmonary disease (COPD). More recently, NIV has shown to reduce the need for intubation in selected groups of patients with severe cardiogenic pulmonary edema, immunosuppression, and respiratory failure after lung resection. In their subgroup analysis of the five randomized control trials, however, patients with acute lung injury (ALI) or ARDS still couldn't avoid intubation and death even treated with NPPV. Till now, there has been no randomized controlled study of NPPV in patients with ALI or ARDS. We hypothesized that in patients with ALI/ARDS, early use of NPPV, providing appropriate inspired oxygen concentrations, would prevent intubation as the primary end-point variable, hence avert the poor outcome associated with the need of invasive ventilation. Accordingly, we conducted a prospective, randomized controlled trial to assess the efficacy of NPPV compared with a standard regime consisting of high-concentration oxygen therapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lung Injury Acute Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

noninvasive positive pressure ventilation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meet the ALI/ARDS criteria

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wang Chen, MD

Role: STUDY_CHAIR

Beijing Chao Yang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing chaoyang hospital-affiliate of capital medical university

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhan Q Yuan, MD

Role: CONTACT

[email protected]
86-10-85231543

Sun Bin, MD

Role: CONTACT

[email protected]
86-0-13911151075

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhan Q Yuan, MD

Role: primary

[email protected]
86-10-65060167

Sun Bin, MS

Role: backup

[email protected]
86-10-85231893

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Y0905001040291

Identifier Type: -

Identifier Source: org_study_id