Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Not Applicable

Completed

• Conditions: Cardiac Surgery; Mechanically Ventilated Patients
• Interventions: Device: Hamilton ventilator (G5 modify to S1) Automated settings; Other: Hamilton ventilator (G5) protocolized settings

• Registration Number: NCT01090258
• Lead Sponsor: Laval University

Brief Summary

The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe.

The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery.

The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.

Detailed Description

Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery

Hypothesis:

Intellivent will maintain the patient with " optimal ventilation " better than during usual management with a minimal number of interventions

Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the " not acceptable " zone of ventilation and duration

Secondary outcome:

Number of episodes in the " acceptable " zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Unexpected surgical procedure
• Major complication during surgery
• Early extubation expected (< 1 hour)
• Broncho-pleural fistula
• Study ventilator not available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated settings	Hamilton ventilator (G5 modify to S1) Automated settings	Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)
protocolized settings	Hamilton ventilator (G5) protocolized settings	Ventilator settings performed by the local respiratory therapists according to the local protocols

Primary Outcome Measures

Name	Time	Method
" not acceptable " zone of ventilation	During the 4 hours of the protocol	Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined