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

Sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01472302

Collaborator

(none)

229

Enrollment

Location

Arms

Duration (Months)

10.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure All Intubated Patients	Device: Adaptive Support Ventilation Device: Pressure Controlled Ventilation	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

229 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Duration of mechanical ventilation [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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

Other Study ID Numbers:

IGCEAH-ICU 2

First Posted:

Nov 16, 2011

Last Update Posted:

Mar 6, 2014

Last Verified:

Mar 1, 2014

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Mar 6, 2014