Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

NCT01090258 | Completed

• 1 other identifier: CS-2009
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiac Surgery; Mechanically Ventilated Patients

Keywords

cardiac surgery; mechanical ventilation; automation; weaning

Outcome Measures

Primary Outcomes (2)

• " 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

• " 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

Study Arms (2)

Automated settings

EXPERIMENTAL

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

protocolized settings

ACTIVE COMPARATOR

Ventilator settings performed by the local respiratory therapists according to the local protocols

Other: Hamilton ventilator (G5) protocolized settings

Interventions

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...)

Also known as: Intellivent

Automated settings

Hamilton ventilator (G5) protocolized settings OTHER

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

protocolized settings

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unexpected surgical procedure
• Major complication during surgery
• Early extubation expected (\< 1 hour)
• Broncho-pleural fistula
• Study ventilator not available

Sponsors & Collaborators

• Laval University: lead

Related Publications (1)

• 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.

  PMID: 23338569 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 25, 2014

Record last verified: 2014-02