Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

July 28, 2016 updated by: Norwegian University of Science and Technology

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • Dept Intensive Care Medicine, St Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Pål Klepstad, MD PhD, National Taiwan Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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