Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller (CLOSER1)

Laval University

Status: Completed

Conditions: Cardiac Surgery; Mechanically Ventilated Patients

Treatments: Device: Hamilton ventilator (G5 modify to S1) Automated settings; Other: Hamilton ventilator (G5) protocolized settings

Study type: Interventional

Funder types: Other

Identifiers

NCT01090258

CS-2009

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Automated settings

Experimental group

Description:

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...)

Treatment:

Device: Hamilton ventilator (G5 modify to S1) Automated settings

protocolized settings

Active Comparator group

Description:

Ventilator settings performed by the local respiratory therapists according to the local protocols

Treatment:

Other: Hamilton ventilator (G5) protocolized settings