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
  Purpose

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.


Condition Intervention
Cardiac Surgery
Mechanically Ventilated Patients
Device: Hamilton ventilator (G5 modify to S1) Automated settings
Other: Hamilton ventilator (G5) protocolized settings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • " 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


Enrollment: 60
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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...)
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
Active Comparator: protocolized settings
Ventilator settings performed by the local respiratory therapists according to the local protocols
Other: Hamilton ventilator (G5) protocolized settings
Mechanical ventilation settings performed by the respiratory therapists according to the local protocols

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: François Lellouche, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT01090258     History of Changes
Other Study ID Numbers: CS-2009
Study First Received: March 18, 2010
Last Updated: February 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
cardiac surgery
mechanical ventilation
automation
weaning

ClinicalTrials.gov processed this record on August 21, 2014