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Helmet CPAP vs Venturi O2 to Treat Early ALI/ARDS (HelmetCPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Catholic University of the Sacred Heart

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Hypoxemic Respiratory Failure Procedure: CPAP delivered by an Helmet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The number of endotracheal intubations over the study period [ Time Frame: period during the ICU stay ]

Secondary Outcome Measures :
  1. The improvement of gas exchange [ Time Frame: period during icu stay ]
  2. The complications not present on admission [ Time Frame: period during the icu stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute Hypoxemic Respiratory failure
  • Severe Dyspnea at rest
  • Pulmonary infiltrates at chest X ray
  • PaO2/FiO2<300
  • Respiratory Rate > 30 breaths/min

Exclusion Criteria:

  • Age < 18 years
  • COPD
  • CPE
  • Patients belonging to Class II-III-IV of the NYHA
  • Unstable angina and myocardial infarction/ cardiac surgery within the previous 3 months
  • Intubation refused or contraindicated
  • Acute Respiratory Acidosis pH < 7.30 and PaCO2 > 50 mmHg
  • More than 3 organ failures
  • Systolic Pressure < 90 mmHg, under fluid resuscitation or Epinephrine or Norepinephrine > 0.1 gamma/Kg/min
  • EKG instability with ventricular arrhythmias
  • EXPECTED surgery during the 48 hours following the enrollment
  • Coma or seizures
  • Decreased level of consciousness (GCS <12)
  • Inability to clear secretions
  • Pre-defined intubation criteria

Information from the National Library of Medicine

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 identifier (NCT number): NCT00342368

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Contact: Massimo Antonelli, Prof +39 06 30 15 3226
Contact: Mariano A Pennisi, Dr. +39 06 30 15 4889

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UCSC, Policlinico Universitario A. Gemelli, ICU Recruiting
Rome, Italy, 00168
Contact: Massimo Antonelli, Prof    +39 06 30 15 32 26   
Contact: Mariano Pennisi, Dr    + 39 06 30 15 43 86   
Principal Investigator: Massimo Antonelli, Prof         
Sponsors and Collaborators
Catholic University of the Sacred Heart
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Study Director: Massimo Antonelli, Prof Catholic University of the Sacred Heart
Layout table for additonal information Identifier: NCT00342368    
Other Study ID Numbers: Prot.pdc181(A.295)/C.E./2004
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007
Keywords provided by Catholic University of the Sacred Heart:
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases