Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients

This study is currently recruiting participants.
Verified May 2013 by University of Lausanne Hospitals
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01695603
First received: September 20, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

Comparison of the ability of a new automated ventilatory mode named Intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. Comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.


Condition Intervention
Brain Injured Patients
Device: Intellivent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparison of a New Automated Ventilatory Mode Named Intellivent to Standard Controlled Ventilation in Brain Injured Patients

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Partial pressure of carbon dioxide [ Designated as safety issue: No ]
    The partial pressure of carbon dioxide (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation


Secondary Outcome Measures:
  • Partial pressure of oxygen [ Designated as safety issue: No ]
    The partial pressure of oxygen (PaCO2) will be recorded every thirty minutes during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Number of alarms generated by the ventilator [ Designated as safety issue: No ]
    The number of alarms generated by the ventilator will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Number of settings modifications [ Designated as safety issue: No ]
    The number of ventilator settings modifications required will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Intracranial pressure [ Designated as safety issue: No ]
    Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Respiratory parameters [ Designated as safety issue: No ]
    Various respiratory parameters tidal volume, respiratory rate, minute ventilation, airway pressure) will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Cerebral vasoreactivity [ Designated as safety issue: No ]
    Cerebral vasoreactivity will be studied from the intracranial pressure and invasive arterial pressure curves recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Partial pressure of oxygen in the brain tissue if available [ Designated as safety issue: No ]
    Partial pressure of oxygen in the brain tissue, if available for clinical reasons, will be recorded during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Number of therapeutic actions needed to reduce intracranial pressure [ Designated as safety issue: No ]
    The number of therapeutic actions needed to reduce intracranial pressure will be recorded during two hours under standard controlled ventilation and during two hours under Intellivent ventilation.

  • Cerebral perfusion pressure [ Designated as safety issue: No ]
    Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation


Estimated Enrollment: 23
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard mode of controlled ventilation
Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.
Device: Intellivent
Two hours of ventilation will be delivered with the Intellivent automated mode and will be compared to two hours during usual controlled ventilation.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke)
  • Glasgow coma scale of 9 or less
  • Controlled mechanical ventilation required
  • Intracranial pressure monitoring required for clinical reasons

Exclusion Criteria:

  • age under 16 years old
  • clinical signs of brainstem lesions
  • patients with withdrawal order or for whom organ donation is under discussion
  • major haemodynamic instability
  • High carbon dioxide alveoloarterial gradient (>10 mmHg) and/or suffering of severe hypoxemia (PaO2/FIO2 < 150 mmHg)
  • Patients included in another interventional clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695603

Contacts
Contact: Philippe Jolliet, Prof +41 79 556 16 50 philippe.jolliet@chuv.ch
Contact: Lise Piquilloud, MD +4179 556 76 42 lise.piquilloud@chuv.ch

Locations
Switzerland
Adult Intensive Care and Burn Unit, University hospital of Lausanne Recruiting
Lausanne, Switzerland, 1012
Contact: Philippe Jolliet, Professor    +41 79 556 16 50    philippe.jolliet@chuv.ch   
Contact: Lise Piquilloud, MD    +4179 556 76 42    lise.piquilloud@chuv.ch   
Principal Investigator: Philippe Jolliet, Professor         
Sub-Investigator: Lise Piquilloud, MD         
Sub-Investigator: Jean-Pierre Revelly, MD         
Sponsors and Collaborators
Prof. Philippe Jolliet
University of Lausanne Hospitals
Investigators
Principal Investigator: Philippe Jolliet, Prof University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01695603     History of Changes
Other Study ID Numbers: Intellibrain
Study First Received: September 20, 2012
Last Updated: May 23, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Laws and standards

Keywords provided by University of Lausanne Hospitals:
Brain injury
Controlled ventilation
Intellivent
Capnia control

ClinicalTrials.gov processed this record on April 17, 2014