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Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients

This study is currently recruiting participants.
Verified May 2012 by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Cenk Kirakli, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01472302
First received: November 11, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Respiratory Failure
Intubated Patients
 Device: Adaptive Support Ventilation
Device: Pressure Controlled Ventilation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital:

Primary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASV Device: Adaptive Support Ventilation
Ventilation protocol according to the patients ideal body weight
Active Comparator: PCV Device: Pressure Controlled Ventilation
Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472302

Contacts
Contact: Cenk Kirakli, Md +905052352024 ckirakli@hotmail.com

Locations
Turkey
Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit Recruiting
Izmir, Yenisehir, Turkey, 35550
Principal Investigator: Cenk Kirakli, MD            
Sponsors and Collaborators
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Investigators
Principal Investigator: Cenk Kirakli, MD Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital
  More Information

No publications provided

Responsible Party: Cenk Kirakli, Principal investigator, Director of ICU, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01472302     History of Changes
Other Study ID Numbers: IGCEAH-ICU 2
Study First Received: November 11, 2011
Last Updated: May 31, 2012
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013