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Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

pressure controlled ventilator

Pressure Regulated Volume Controlled Ventilator

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dept Intensive Care Medicine, St Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PC ventilation

PRVC ventilation

Arm Description

Intervention with pressure controlled ventilator

Intervention with Pressure Regulated Volume Controlled Ventilator

Outcomes

Primary Outcome Measures

ICP

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

Secondary Outcome Measures

PaCO2

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

Full Information

NCT ID

NCT01955785

First Posted

September 30, 2013

Last Updated

July 28, 2016

Sponsor

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT01955785

Brief Title

Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PC ventilation

Arm Type

Active Comparator

Arm Description

Intervention with pressure controlled ventilator

Arm Title

PRVC ventilation

Arm Type

Active Comparator

Arm Description

Intervention with Pressure Regulated Volume Controlled Ventilator

Intervention Type

Device

Intervention Name(s)

pressure controlled ventilator

Intervention Type

Device

Intervention Name(s)

Pressure Regulated Volume Controlled Ventilator

Primary Outcome Measure Information:

Title

ICP

Description

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 Outcome Measure Information:

Title

PaCO2

Description

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

Time Frame

Two hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pål Klepstad, MD PhD

Organizational Affiliation

National Taiwan Normal University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept Intensive Care Medicine, St Olavs University Hospital

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

26503512

Citation

Schirmer-Mikalsen K, Vik A, Skogvoll E, Moen KG, Solheim O, Klepstad P. Intracranial Pressure During Pressure Control and Pressure-Regulated Volume Control Ventilation in Patients with Traumatic Brain Injury: A Randomized Crossover trial. Neurocrit Care. 2016 Jun;24(3):332-41. doi: 10.1007/s12028-015-0208-8.

Results Reference

result

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Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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