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OpenTrials
Completed

NCT Number: NCT01955785

Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Intensive Care Medicine, St Olavs University Hospital

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pressure controlled ventilator

Device

Pressure Regulated Volume Controlled Ventilator

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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