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Helmet CPAP vs Venturi O2 to Treat Early ALI/ARDS

NCT00342368 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2007-11-01

No results posted yet for this study

Summary

Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, and represents one of the most important predisposing factors for developing nosocomial bacterial pneumonia.

In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a safe and effective mean for treating patients with acute respiratory failure (ARF), improving gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial mask, that is the conventional interface for NIV, may induce intolerance because of pain, discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and endotracheal intubation. Thus the improvement of the interface between patient and ventilator seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive ventilation. Attempting to improve tolerability of patients we used a new interface consisting in Helmet made in latex-free PVC.

No prospective randomized controlled study has been published on the comparison between Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment with Oxygen supplementation to treat early acute respiratory failure and acute lung injury.

Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).

Conditions

  • Acute Hypoxemic Respiratory Failure

Interventions

PROCEDURE

CPAP delivered by an Helmet

continuous positive airway pressures delivered through an helmet

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Massimo Antonelli, Prof · Catholic University of the Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2009-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00342368 on ClinicalTrials.gov