Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Cardiac Surgery Clinical Trial

— CLOSER1  

Official title:

Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090258
• Other study ID #: CS-2009
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: February 24, 2014
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2014
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Mechanically Ventilated Patients

Intervention

Device:
• 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...)

Other:
• Hamilton ventilator (G5) protocolized settings
Mechanical ventilation settings performed by the respiratory therapists according to the local protocols

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	" not acceptable " zone of ventilation	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	Yes
Primary	" not acceptable " zone of ventilation	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	Yes