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Completed

NCT Number: NCT01695603

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

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.

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Key information

Conditions

Brain Injured Patients Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Intensive Care and Burn Unit, University hospital of Lausanne

Lausanne, 1012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intellivent

Device

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Intracranial pressure

    Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation

  5. 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

  6. 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

  7. 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

  8. 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.

  9. Cerebral perfusion pressure

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

Sponsors and collaborators

Lead sponsor

Prof. Philippe Jolliet

Other

Collaborators

  • University of Lausanne Hospitals

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2012
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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