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

Prof. Philippe Jolliet

Status: Completed

Conditions: Brain Injured Patients

Treatments: Device: Intellivent

Study type: Interventional

Funder types: Other

Identifiers

NCT01695603

Intellibrain

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Standard mode of controlled ventilation

No Intervention group

Description:

Each brain injured patient will be ventilated during two hours with a standard mode of controlled ventilation.

Intellivent arm

Experimental group

Description:

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

Treatment:

Device: Intellivent