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Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

NCT01090258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-02-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Laval University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090258 on ClinicalTrials.gov