Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Surgery
- Sponsor
- Laval University
- Enrollment
- 60
- Primary Endpoint
- " not acceptable " zone of ventilation
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
François Lellouche
Professeur
Laval University
Eligibility Criteria
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
Outcomes
Primary Outcomes
" not acceptable " zone of ventilation
Time Frame: 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