NCT01955785

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

September 30, 2013

Last Update Submit

July 28, 2016

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injuryIntracranial pressureVentilationRespiratory therapy

Outcome Measures

Primary Outcomes (1)

  • ICP

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

    Two hours

Secondary Outcomes (1)

  • PaCO2

    Two hours

Study Arms (2)

PC ventilation

ACTIVE COMPARATOR

Intervention with pressure controlled ventilator

Device: pressure controlled ventilator

PRVC ventilation

ACTIVE COMPARATOR

Intervention with Pressure Regulated Volume Controlled Ventilator

Device: Pressure Regulated Volume Controlled Ventilator

Interventions

pressure controlled ventilatorDEVICE
PC ventilation
Pressure Regulated Volume Controlled VentilatorDEVICE
PRVC ventilation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Intensive Care Medicine, St Olavs University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26503512RESULT

MeSH Terms

Conditions

Brain Injuries, TraumaticRespiratory Aspiration

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pål Klepstad, MD PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

NO(1)