Helmet CPAP vs Venturi O2 to Treat Early ALI/ARDS (HelmetCPAP)
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|ClinicalTrials.gov Identifier: NCT00342368|
Recruitment Status : Unknown
Verified October 2007 by Catholic University of the Sacred Heart.
Recruitment status was: Recruiting
First Posted : June 21, 2006
Last Update Posted : November 1, 2007
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Hypoxemic Respiratory Failure||Procedure: CPAP delivered by an Helmet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of CPAP Delivered by Helmet and O2 Therapy With a Venturi Mask as First Line Intervention in Early ALI/ARDS|
|Study Start Date :||June 2005|
|Estimated Study Completion Date :||March 2009|
Active Comparator: 1
CPAP through an helmet
Procedure: CPAP delivered by an Helmet
continuous positive airway pressures delivered through an helmet
No Intervention: 2
O2 therapy with conventional face mask
- The number of endotracheal intubations over the study period [ Time Frame: period during the ICU stay ]
- The improvement of gas exchange [ Time Frame: period during icu stay ]
- The complications not present on admission [ Time Frame: period during the icu stay ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342368
|Contact: Massimo Antonelli, Prof||+39 06 30 15 firstname.lastname@example.org|
|Contact: Mariano A Pennisi, Dr.||+39 06 30 15 email@example.com|
|UCSC, Policlinico Universitario A. Gemelli, ICU||Recruiting|
|Rome, Italy, 00168|
|Contact: Massimo Antonelli, Prof +39 06 30 15 32 26 firstname.lastname@example.org|
|Contact: Mariano Pennisi, Dr + 39 06 30 15 43 86 email@example.com|
|Principal Investigator: Massimo Antonelli, Prof|
|Study Director:||Massimo Antonelli, Prof||Catholic University of the Sacred Heart|