- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01090258
Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller (CLOSER1)
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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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...)
|
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:
|
Active Comparator: protocolized settings
Ventilator settings performed by the local respiratory therapists according to the local protocols
|
Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
" 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
|
During the four hours of the study protocol
|
" 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
|
During the 4 hours of the protocol
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CS-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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