Back to resultsClosed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
Primary Purpose
Respiratory Failure, All Intubated Patients
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Adaptive Support Ventilation
Pressure Controlled Ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Intubated and mechanically ventilated ICU patients for more than 24 hours
Exclusion Criteria:
- Patient with a tracheostomy
- Patients under home mechanical ventilation
Sites / Locations
- Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ASV
PCV
Arm Description
Adaptive Support Ventilation
Pressure Controlled Ventilation
Outcomes
Primary Outcome Measures
Duration of mechanical ventilation
Secondary Outcome Measures
Full Information
NCT ID
NCT01472302
First Posted
November 11, 2011
Last Updated
March 5, 2014
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01472302
Brief Title
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, All Intubated Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASV
Arm Type
Experimental
Arm Description
Adaptive Support Ventilation
Arm Title
PCV
Arm Type
Active Comparator
Arm Description
Pressure Controlled Ventilation
Intervention Type
Device
Intervention Name(s)
Adaptive Support Ventilation
Intervention Description
Ventilation protocol according to the patients ideal body weight
Intervention Type
Device
Intervention Name(s)
Pressure Controlled Ventilation
Intervention Description
Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU
Primary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intubated and mechanically ventilated ICU patients for more than 24 hours
Exclusion Criteria:
Patient with a tracheostomy
Patients under home mechanical ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenk Kirakli, MD
Organizational Affiliation
Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
City
Izmir
State/Province
Yenisehir
ZIP/Postal Code
35550
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
25742308
Citation
Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.
Results Reference
derived
Learn more about this trial
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
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