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

NCT01695603 | Completed

• 1 other identifier: Intellibrain
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injured Patients

Keywords

Brain injury; Controlled ventilation; Intellivent; Capnia control

Outcome Measures

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 (9)

• Partial pressure of oxygen

• Number of alarms generated by the ventilator

• Number of settings modifications

• Intracranial pressure

• Respiratory parameters

Study Arms (2)

Standard mode of controlled ventilation

NO INTERVENTION

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

Intellivent arm

EXPERIMENTAL

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

Device: Intellivent

Interventions

Intellivent DEVICE

Intellivent arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Philippe Jolliet: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Adult Intensive Care and Burn Unit, University hospital of Lausanne

Lausanne, 1012, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Philippe Jolliet, Prof

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Main investigator

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 28, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CH (1)