Clinical trial NCT02507973: Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury
Official title: Study of APRV and ICP in Patients With Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Injury, Brain, Traumatic
Traumatic Brain Injury
Keywords: Mechanical Ventilation
Intracranial Pressure
Airway Pressure Release Ventilation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 8
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with intracranial pressure monitor requiring mechanical ventilation support will be eligible for enrollment in the study

Brief summary: The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center.

Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.

Detailed description: Each participant at admission will initially receive a primary mode of mechanical ventilation as determined by the attending trauma intensivists. 12-18 hours after recruitment, continuous monitoring of participants' ICP and hemodynamic status will commence to collect participants' baseline data for 30 minutes.

Participants will then undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation, for 2 hours prior to switching back to the primary mode of ventilation for 30 minutes. Next, patients will be placed on Airway Pressure Release Ventilation (APRV) for 2 hours. While receiving APRV, participants Intracranial pressure and hemodynamic status will be continuously monitored and recorded for comparison and analysis. After 2 hours of APRV, patients will be switched back to their previous mode of ventilation and more data collected for another 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Intracranial Pressure Monitoring device present
* Mechanically Ventilated
* Clinically Stable as determined by the Critical Care attending

Exclusion Criteria:

* Age \<14
* Prisoners
* Initial Mode of ventilation is APRV
* Provider's Judgement
* Pregnant

Primary outcomes:
measure: Intracranial Pressure
timeFrame: On average, 24 hours for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: RA Cowley Shock Trauma Center
state: Maryland
Study officials:
affiliation: Professor, Department of Surgery
name: Deborah M Stein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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