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NCT01472302 Clinical Trial

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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01472302
Other study ID # IGCEAH-ICU 2
Secondary ID
Status Completed
Phase Phase 4
First received November 11, 2011
Last updated March 5, 2014
Start date April 2012
Est. completion date January 2014

Study information
Verified date March 2014
Source Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 229
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Adaptive Support Ventilation
Ventilation protocol according to the patients ideal body weight
• Pressure Controlled Ventilation
Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU

Locations
Country Name City State
Turkey Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit Izmir Yenisehir

Sponsors (1)
Lead Sponsor Collaborator
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of mechanical ventilation 1 year No
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