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

NCT ID: NCT00331656

Last Updated: 2008-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Respiratory Insufficiency; Chronic Obstructive Pulmonary Disease; Pneumonia; Pulmonary Edema; Neuromuscular Diseases

Keywords

noninvasive; positive; cuirass; ventilation; respiratory; failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Non-invasive positive pressure mask ventilators

Intervention Type: DEVICE

Extrathoracic biphasic cuirass ventilator (RTX, Hayek)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Sigal Sviri, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Sigal Sviri, MD

Role: CONTACT

Phone: 00 972 2 6777111

Email: sisviri@md.huji.ac.il

David M Linton, MD

Role: CONTACT

Phone: 00 972 2 6777111

Email: dlinton@hadassah.org.il

Facility Contacts

Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

References

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. doi: 10.1378/chest.121.1.189.

Reference Type: BACKGROUND

PMID: 11796450 (View on PubMed)

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. doi: 10.1007/s00134-003-2145-9. Epub 2004 Jan 21.

Reference Type: BACKGROUND

PMID: 14735237 (View on PubMed)

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. doi: 10.1378/chest.125.6.2217.

Reference Type: BACKGROUND

PMID: 15189944 (View on PubMed)

Other Identifiers

NIVCOMPARE-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id