- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01472302
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
March 5, 2014 updated by: Cenk Kirakli, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Effect of a Closed Loop Ventilation Strategy on Reducing the Total Duration of Mechanical Ventilation of Intubated Intensive Care Unit Patients: A Randomized Controlled Trial
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically.
Some studies suggest that ASV can reduce the weaning time in ICU patients.
The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
229
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenisehir
-
Izmir, Yenisehir, Turkey, 35550
- Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Intubated and mechanically ventilated ICU patients for more than 24 hours
Exclusion Criteria:
- Patient with a tracheostomy
- Patients under home mechanical ventilation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ASV
Adaptive Support Ventilation
|
Ventilation protocol according to the patients ideal body weight
|
|
Active Comparator: PCV
Pressure Controlled Ventilation
|
Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of mechanical ventilation
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cenk Kirakli, MD, Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
November 11, 2011
First Submitted That Met QC Criteria
November 15, 2011
First Posted (Estimate)
November 16, 2011
Study Record Updates
Last Update Posted (Estimate)
March 6, 2014
Last Update Submitted That Met QC Criteria
March 5, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGCEAH-ICU 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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