Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955785
• Other study ID #: 2013/1346
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: July 28, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• pressure controlled ventilator

• Pressure Regulated Volume Controlled Ventilator

Locations

Country	Name	City	State
Norway	Dept Intensive Care Medicine, St Olavs University Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICP	Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design	Two hours	No
Secondary	PaCO2	Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design	Two hours	No