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

Brain Injured Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695603
• Other study ID #: Intellibrain
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: May 3, 2017
• Start date: March 2012
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injured Patients

Intervention

Device:
• Intellivent

Locations

Country	Name	City	State
Switzerland	Adult Intensive Care and Burn Unit, University hospital of Lausanne	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Philippe Jolliet	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Intracranial pressure	Intracranial pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Cerebral perfusion pressure	Cerebral perfusion pressure will be recorded continuously during 2 hours under standard controlled ventilation and during 2 hours under Intellivent ventilation