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

Prof. Philippe Jolliet23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Brain Injured Patients

Interventions

IntelliventDEVICE

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Adult Intensive Care and Burn Unit, University hospital of Lausanne

Lausanne, Switzerland

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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