Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS)

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Device: the application of NPPV; Device: invasive ventilation

• Registration Number: NCT00644930
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.

Detailed Description

Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-09
• Study Completion: 2007-12
• Status Verified: 2008-03
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-27
• Last Update Posted: 2008-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

The following criteria indicated immediate intubation was needed:

1. Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest.
2. Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2>0.6.
3. Inability to increase the patient's pH levels above 7.35, and development of blurred consciousness and confusion (Glasgow Coma Scale <9) due to respiratory acidosis despite all the support given.
4. Instability of the patient's hemodynamic parameters (such as systolic blood pressure <80 mmHg or heart rate <50 beats/minute lasting >1 hour despite fluid resuscitation).

Exclusion Criteria

Contraindications for NPPV include:

1. The need for urgent intubation.
2. The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
3. Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	the application of NPPV	ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated.
2	invasive ventilation	Patients in the standard therapy group without indications for urgent intubation were only given standard medical therapy (such as oxygen, antibiotics, and bronchodilators), and IMV through an endotracheal tube was applied when intubation criteria were met.

Primary Outcome Measures

Name	Time	Method
Intubation rate	48 hours

Secondary Outcome Measures

Name	Time	Method
Hospital mortality

Trial Locations

Locations (1)

Eskisehir Osmangazi University, Medical Faculty,; 🇹🇷 Eskisehir, Merkez, Turkey