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.

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Key information

Conditions

Cardiac Surgery Mechanically Ventilated Patients

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hamilton ventilator (G5 modify to S1) Automated settings

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...)

Other names: Intellivent

Hamilton ventilator (G5) protocolized settings

Other

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

Primary outcomes

" not acceptable " zone of ventilation

Time frame: 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
" 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Acronym: CLOSER1

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 19, 2010
Registry last updated: Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed