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Clinical Trials/NCT00644930
NCT00644930
Completed
N/A

The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study

Eskisehir Osmangazi University1 site in 1 country20 target enrollmentAugust 2003

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Eskisehir Osmangazi University
Enrollment
20
Locations
1
Primary Endpoint
Intubation rate
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2003
End Date
December 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eskisehir Osmangazi University

Eligibility Criteria

Inclusion Criteria

  • The following criteria indicated immediate intubation was needed:
  • Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest.
  • Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2\>0.
  • 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.
  • 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:
  • The need for urgent intubation.
  • The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
  • Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.

Outcomes

Primary Outcomes

Intubation rate

Time Frame: 48 hours

Secondary Outcomes

  • Hospital mortality

Study Sites (1)

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