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

This study has been completed.
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 3, 2017
Last verified: May 2017
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
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
    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
    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
    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
    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
    Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  • Respiratory parameters
    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
    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
    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
    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
    Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation


Enrollment: 23
Study Start Date: March 2012
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard mode of controlled ventilation
Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.
Experimental: Intellivent arm
Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode.
Device: Intellivent

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695603

Locations
Switzerland
Adult Intensive Care and Burn Unit, University hospital of Lausanne
Lausanne, Switzerland, 1012
Sponsors and Collaborators
Prof. Philippe Jolliet
University of Lausanne Hospitals
Investigators
Principal Investigator: Philippe Jolliet, Prof University of Lausanne Hospitals
  More Information

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 3, 2017

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

ClinicalTrials.gov processed this record on May 22, 2017