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.

Study Overview

• Status: Completed
• Conditions: Brain Injured Patients
• Intervention / Treatment: Device: Intellivent

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1012
    • Adult Intensive Care and Burn Unit, University hospital of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Prof. Philippe Jolliet
• Collaborators: University of Lausanne Hospitals
• Investigators: Principal Investigator: Philippe Jolliet, Prof, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Brain injury; Controlled ventilation; Intellivent; Capnia control
• Other Study ID Numbers: Intellibrain