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Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury

Terminated
Conditions
Traumatic Brain Injury
Injury, Brain, Traumatic
Interventions
Other: Low Tidal Volume Ventilation
Other: Airway Pressure Release Ventilation
Registration Number
NCT02507973
Lead Sponsor
University of Maryland, Baltimore
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
8
Inclusion Criteria
  • Intracranial Pressure Monitoring device present
  • Mechanically Ventilated
  • Clinically Stable as determined by the Critical Care attending
Read More
Exclusion Criteria
  • Age <14
  • Prisoners
  • Initial Mode of ventilation is APRV
  • Provider's Judgement
  • Pregnant
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Low Tidal Volume Ventilation:LOTVLow Tidal Volume VentilationEach participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and LOTV on patient intracranial pressure and hemodynamic values.
Airway Pressure Release Ventilation:APRVAirway Pressure Release VentilationEach participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.
Primary Outcome Measures
NameTimeMethod
Intracranial PressureOn average, 24 hours for each patient

We aim to evaluate the patients during the two modes of ventilation (LTOV and APRV) to determine if there are significant differences in their ICP based on ventilation mode.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

RA Cowley Shock Trauma Center

🇺🇸

Baltimore, Maryland, United States

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