Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

Brief Summary

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Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PC ventilation

Intervention with pressure controlled ventilator

Group Type ACTIVE_COMPARATOR

pressure controlled ventilator

Intervention Type DEVICE

PRVC ventilation

Intervention with Pressure Regulated Volume Controlled Ventilator

Group Type ACTIVE_COMPARATOR

Pressure Regulated Volume Controlled Ventilator

Intervention Type DEVICE

Interventions

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pressure controlled ventilator

Intervention Type DEVICE

Pressure Regulated Volume Controlled Ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained from the patients next-of-kin.
* moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
* treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
* intubated and receiving controlled mechanical ventilation.
* continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
* sedation to a level of sedation corresponding to MAAS (Motor Activity Assessment Score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14.

Exclusion Criteria

* Pregnancy
* ICP above 25 mmHg
* ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
* continuous external drainage of cerebrospinal fluid (CSF)
* Clinical pulmonary condition prohibiting changes in respiratory therapy

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No