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

This study has been completed.
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: March 5, 2014
Last verified: March 2014
  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
All 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:


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 ]

Enrollment: 229
Study Start Date: April 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASV
Adaptive Support Ventilation
Device: Adaptive Support Ventilation
Ventilation protocol according to the patients ideal body weight
Active Comparator: PCV
Pressure Controlled Ventilation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472302

Locations
Turkey
Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Izmir, Yenisehir, Turkey, 35550
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: March 5, 2014
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014