Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cardiac Surgery Mechanically Ventilated Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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...)

Group Type EXPERIMENTAL

Hamilton ventilator (G5 modify to S1) Automated settings

Intervention Type DEVICE

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...)

protocolized settings

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

Group Type ACTIVE_COMPARATOR

Hamilton ventilator (G5) protocolized settings

Intervention Type OTHER

Mechanical ventilation settings performed by the respiratory therapists according to the local protocols

Interventions

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Hamilton 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...)

Intervention Type DEVICE

Hamilton ventilator (G5) protocolized settings

Mechanical ventilation settings performed by the respiratory therapists according to the local protocols

Intervention Type OTHER

Other Intervention Names

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Intellivent

Eligibility Criteria

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Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No