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

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00331656

Purpose

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	Intervention	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 IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Edema Neuromuscular Disorders Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Non-Invasive Positive Pressure Mask Ventilation vs Extrathoracic Biphasic Cuirass Ventilation in Patients With Acute Respiratory Failure: A Randomized Prospective Study.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Need for endotracheal intubation
ICU and hospital mortality using the two modes

Secondary Outcome Measures:

Length of ventilation
Length of ICU and hospital stay
Complication rates using the two modes.

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331656

Contacts

Contact: Sigal Sviri, MD	00 972 2 6777111	sisviri@md.huji.ac.il
Contact: David M Linton, MD	00 972 2 6777111	dlinton@hadassah.org.il

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Sigal Sviri, MD

Hadassah Medical Organization, Jerusalem, Israel

More Information

Publications:

Corrado A, Confalonieri M, Marchese S, Mollica C, Villella G, Gorini M, Della Porta R. Iron lung vs mask ventilation in the treatment of acute on chronic respiratory failure in COPD patients: a multicenter study. Chest. 2002 Jan;121(1):189-95.

Gorini M, Ginanni R, Villella G, Tozzi D, Augustynen A, Corrado A. Non-invasive negative and positive pressure ventilation in the treatment of acute on chronic respiratory failure. Intensive Care Med. 2004 May;30(5):875-81. Epub 2004 Jan 21.

Todisco T, Baglioni S, Eslami A, Scoscia E, Todisco C, Bruni L, Dottorini M. Treatment of acute exacerbations of chronic respiratory failure: integrated use of negative pressure ventilation and noninvasive positive pressure ventilation. Chest. 2004 Jun;125(6):2217-23.

Study ID Numbers:	NIVCOMPARE-HMO-CTIL
Study First Received:	May 30, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00331656
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

noninvasive
positive
cuirass

ventilation
respiratory
failure

Study placed in the following topic categories:

Respiratory Distress Syndrome, Adult
Respiration Disorders
Edema
Lung Diseases, Obstructive
Pulmonary Edema
Respiratory Insufficiency
Neuromuscular Diseases

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Acute respiratory distress syndrome
Pneumonia
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009