Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331656
Status:
UNKNOWN
Last Update Posted:
2008-05-07
First Post:
2006-05-30
Brief Title:
Comparative Study of Non-Invasive Mask Ventilation vs Cuirass Ventilation in Patients With Acute Respiratory Failure
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Non-Invasive Positive Pressure Mask Ventilation vs Extrathoracic Biphasic Cuirass Ventilation in Patients With Acute Respiratory Failure A Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None