Cardiac Surgery Clinical Trial
Official title:
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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