Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Device: pressure controlled ventilator
* Device: Pressure Regulated Volume Controlled Ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PC ventilation<br>Intervention with pressure controlled ventilator | Device: pressure controlled ventilator<br> <br> |
| Active Comparator: PRVC ventilation<br>Intervention with Pressure Regulated Volume Controlled Ventilator | Device: Pressure Regulated Volume Controlled Ventilator<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICP | Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 | Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design | Two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy