Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

N/ACompletedNCT01955785

Norwegian University of Science and Technology11 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

pressure controlled ventilatorDEVICE

Pressure Regulated Volume Controlled VentilatorDEVICE

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept Intensive Care Medicine, St Olavs University Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

ICP

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

Time frame: Two hours

Secondary Outcomes

PaCO2

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

Time frame: Two hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.