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Comparative Study of Non-Invasive Mask Ventilation vs Cuirass Ventilation in Patients With Acute Respiratory Failure.

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: NCT00331656
Recruitment Status : Unknown
Verified May 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2006
Last Update Posted : May 7, 2008
Information provided by:
Hadassah Medical Organization

Brief Summary:
Non-invasive ventilation has become increasingly important in the management of patients with acute respiratory failure. One of its major goals is to prevent the need for invasive ventilation, which is associated with numerous complications. This study compares the usefulness and safety of two noninvasive techniques which are used in Medical practice: Noninvasive positive pressure ventilation using a face mask and extrathoracic biphasic ventilation using a cuirass. Each of these techniques has advantages and disadvantages and both may not suit all patients. It is therefore important to compare the two in terms of effectiveness in preventing invasive ventilation and their side effects profile, so that we can improve our understanding and expertise in the treatment of patients in respiratory failure.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Chronic Obstructive Pulmonary Disease Pneumonia Pulmonary Edema Neuromuscular Diseases Device: Non-invasive positive pressure mask ventilators Device: Extrathoracic biphasic cuirass ventilator (RTX, Hayek) Phase 4

Detailed Description:

Non-invasive ventilation is becoming a frequent and important treatment option for patients with acute respiratory failure, in order to avoid endotracheal intubation and associated complications. Non-invasive techniques include positive pressure mask ventilation, negative (iron lung) ventilation and extrathoracic biphasic cuirass ventilation. However, large, prospective randomized trials comparing these techniques are lacking.

This prospective, randomized study will compare the effectiveness and side effects of non-invasive positive pressure mask ventilation vs extrathoracic biphasic cuirass ventilation in patients with acute respiratory failure.

Methods: Medical patients with acute respiratory failure caused by different etiologies, not requiring immediate endotracheal intubation, will be randomized to receive either positive pressure via face mask or extrathoracic biphasic ventilation via cuirass. Clinical response and/or the need for intubation and mechanical ventilation will be assessed throughout the study. Cross-over to the alternative mode will be provided in case of intolerance or lack of response.

Study endpoints: Need for endotracheal intubation, ICU and hospital mortality, length of ventilation, length of ICU and hospital stay and complication rates using the two modes.

Importance & implications: No studies have yet compared these two modes of noninvasive ventilation in acute respiratory failure. This study can improve our understanding and evidence based knowledge in the treatment of patients with acute respiratory failure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Positive Pressure Mask Ventilation vs Extrathoracic Biphasic Cuirass Ventilation in Patients With Acute Respiratory Failure: A Randomized Prospective Study.
Study Start Date : June 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Need for endotracheal intubation
  2. ICU and hospital mortality using the two modes

Secondary Outcome Measures :
  1. Length of ventilation
  2. Length of ICU and hospital stay
  3. Complication rates using the two modes.

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:

Medical patients with acute respiratory failure caused by different etiologies:

COPD exacerbation, cardiogenic pulmonary edema, pneumonia, ARDS and neuromuscular disorders patients admitted to the Medical Intensive Care Unit

Exclusion Criteria:

Patients or family members who refuse consent for the study, Patients requiring endotracheal intubation, Post-operative patients, Patients who require sedation, Patients who are unconscious or uncooperative, Patients with acute severe asthma, Patients with massive or submassive pulmonary embolism, Patients in shock of any etiology who are hemodynamically unstable, Patients with upper airway obstruction, Patients with upper GI bleeding or epistaxis, Facial deformity or trauma, Patients who are unable to maintain a patent airway, Pregnancy, Patients under 18

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): NCT00331656

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Contact: Sigal Sviri, MD 00 972 2 6777111
Contact: David M Linton, MD 00 972 2 6777111

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Hadassah Medical Organization
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Sigal Sviri, MD         
Principal Investigator: David Linton, MD         
Sub-Investigator: Abed Bayya, MD         
Sub-Investigator: Olga Shatz, MD         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Sigal Sviri, MD Hadassah Medical Organization
Layout table for additonal information Identifier: NCT00331656    
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2006
Keywords provided by Hadassah Medical Organization:
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Pulmonary Edema
Neuromuscular Diseases
Pulmonary Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases