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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
François Lellouche, Laval University
ClinicalTrials.gov Identifier:
NCT01090258
First received: March 18, 2010
Last updated: February 24, 2014
Last verified: February 2014

March 18, 2010
February 24, 2014
July 2009
December 2009   (final data collection date for primary outcome measure)
  • " not acceptable " zone of ventilation [ Time Frame: During the four hours of the study protocol ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of episodes, duration and percentage of time in the " not acceptable " zone of ventilation as pre-defined
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Complete list of historical versions of study NCT01090258 on ClinicalTrials.gov Archive Site
Not Provided
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Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiac Surgery
  • Mechanically Ventilated Patients
  • 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 Name: Intellivent
  • Other: Hamilton ventilator (G5) protocolized settings
    Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
  • 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...)
    Intervention: Device: Hamilton ventilator (G5 modify to S1) Automated settings
  • Active Comparator: protocolized settings
    Ventilator settings performed by the local respiratory therapists according to the local protocols
    Intervention: Other: Hamilton ventilator (G5) protocolized settings
Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01090258
CS-2009
No
François Lellouche, Laval University
Laval University
Not Provided
Not Provided
Laval University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP