NCT00331656

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

Non-Invasive Positive Pressure Mask Ventilation vs Extrathoracic Biphasic Cuirass Ventilation in Patients With Acute Respiratory Failure: A Randomized Prospective Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Non-invasive positive pressure mask ventilators
DEVICE	Extrathoracic biphasic cuirass ventilator (RTX, Hayek)

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2006-05-31
• Last updated: 2008-05-07

Locations

1 site across 1 country: Israel