Comparative Study of Non-Invasive Mask Ventilation vs Cuirass Ventilation in Patients With Acute Respiratory Failure.
Recruitment status was: Not yet recruiting
|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|
|Study Design:||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.|
- Need for endotracheal intubation
- ICU and hospital mortality using the two modes
- Length of ventilation
- Length of ICU and hospital stay
- Complication rates using the two modes.
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331656
|Contact: Sigal Sviri, MD||00 972 2 firstname.lastname@example.org|
|Contact: David M Linton, MD||00 972 2 email@example.com|
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Sigal Sviri, MD|
|Principal Investigator: David Linton, MD|
|Sub-Investigator: Abed Bayya, MD|
|Sub-Investigator: Olga Shatz, MD|
|Principal Investigator:||Sigal Sviri, MD||Hadassah Medical Organization|