Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: Pressure Regulated Volume Controlled Ventilator; Device: pressure controlled ventilator

• Registration Number: NCT01955785
• Lead Sponsor: Norwegian University of Science and Technology

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRVC ventilation	Pressure Regulated Volume Controlled Ventilator	Intervention with Pressure Regulated Volume Controlled Ventilator
PC ventilation	pressure controlled ventilator	Intervention with pressure controlled ventilator

Primary Outcome Measures

Name	Time	Method
ICP	Two hours	Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design

Secondary Outcome Measures

Name	Time	Method
PaCO2	Two hours	Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design

Trial Locations

Locations (1)

Dept Intensive Care Medicine, St Olavs University Hospital; 🇳🇴 Trondheim, Norway