Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01955785

Enrollment

Registered

2013-10-08

Start date

2013-09-30

Completion date

2015-09-30

Last updated

2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy

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).

Interventions

DEVICEpressure controlled ventilator

DEVICEPressure Regulated Volume Controlled Ventilator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
ICP	Two hours	Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design

Secondary

Measure	Time frame	Description
PaCO2	Two hours	Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026