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

Not Applicable

Completed

• Conditions: Brain Injured Patients
• Interventions: Device: Intellivent

• Registration Number: NCT01695603
• Lead Sponsor: Prof. Philippe Jolliet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intellivent arm	Intellivent	Each brain injured patient will be ventilated during two hours with an automated mode of ventilation, the Intellivent mode.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Cerebral perfusion pressure		Cerebral perfusion pressure will be recorded continuously 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.

Trial Locations

Locations (1)

Adult Intensive Care and Burn Unit, University hospital of Lausanne; 🇨🇭 Lausanne, Switzerland