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

NCT ID: NCT01695603

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injured Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard mode of controlled ventilation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intellivent arm

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

Group Type EXPERIMENTAL

Intellivent

Intervention Type DEVICE

Interventions

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Intellivent

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Prof. Philippe Jolliet

OTHER

Sponsor Role lead

Responsible Party

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Prof. Philippe Jolliet

Main investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Philippe Jolliet, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Adult Intensive Care and Burn Unit, University hospital of Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Intellibrain

Identifier Type: -

Identifier Source: org_study_id

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