ClinicalTrials.Veeva

Menu

Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

N

Norwegian University of Science and Technology

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Device: pressure controlled ventilator
Device: Pressure Regulated Volume Controlled Ventilator

Study type

Interventional

Funder types

Other

Identifiers

NCT01955785
2013/1346

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

11 participants in 2 patient groups

PC ventilation
Active Comparator group
Description:
Intervention with pressure controlled ventilator
Treatment:
Device: pressure controlled ventilator
PRVC ventilation
Active Comparator group
Description:
Intervention with Pressure Regulated Volume Controlled Ventilator
Treatment:
Device: Pressure Regulated Volume Controlled Ventilator

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems