Cardiac Surgery, Mechanically Ventilated Patients
Conditions
Keywords
cardiac surgery, mechanical ventilation, automation, weaning
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
Interventions
DEVICEHamilton ventilator (G5 modify to S1) Automated settings
Automated settings (respiratory rate \[RR\], FiO2, Insp and exp pressures) 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...)
OTHERHamilton ventilator (G5) protocolized settings
Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Criteria for consent (before surgical procedure): * Elective cardiac surgery * Age 18 to 90 years * Absence of pregnancy * Body Mass Index \< 40 kg/m² * Creatinine \< 200micromol/L) * Baseline PaCO2 \> 50 mmHg)
Exclusion criteria
* Unexpected surgical procedure * Major complication during surgery * Early extubation expected (\< 1 hour) * Broncho-pleural fistula * Study ventilator not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| not acceptable zone of ventilation | During the four hours of the study protocol | Number of episodes, duration and percentage of time in the not acceptable zone of ventilation as pre-defined |
Outcome results
None listed