Back to resultsAdaptive Support Ventilation in the Weaning of COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Comparison of two different modes for weaning from mechanical ventilation
Sponsored by
About this trial
This is an interventional screening trial for Pulmonary Disease, Chronic Obstructive focused on measuring weaning, adaptive support ventilation, COPD
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD
- On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure
Exclusion Criteria:
- Mechanical ventilation less then 24 hours (self extubation or death),
- Having a tracheotomy and
- COPD coexisted with severe cardiac or neurologic diseases.
Sites / Locations
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pressure support ventilation
Adaptive support ventilation
Arm Description
Outcomes
Primary Outcome Measures
Weaning duration
Secondary Outcome Measures
Weaning success
Length of stay in the ICU
Full Information
NCT ID
NCT00969605
First Posted
August 31, 2009
Last Updated
May 26, 2010
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00969605
Brief Title
Adaptive Support Ventilation in the Weaning of COPD
Official Title
Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
weaning, adaptive support ventilation, COPD
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure support ventilation
Arm Type
Active Comparator
Arm Title
Adaptive support ventilation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Comparison of two different modes for weaning from mechanical ventilation
Other Intervention Name(s)
weaning protocol
Intervention Description
Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.
Primary Outcome Measure Information:
Title
Weaning duration
Secondary Outcome Measure Information:
Title
Weaning success
Title
Length of stay in the ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure
Exclusion Criteria:
Mechanical ventilation less then 24 hours (self extubation or death),
Having a tracheotomy and
COPD coexisted with severe cardiac or neurologic diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenk Kirakli, MD
Organizational Affiliation
Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
City
Izmir
ZIP/Postal Code
35210
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Adaptive Support Ventilation in the Weaning of COPD
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