Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury
- Conditions
- Traumatic Brain InjuryInjury, Brain, Traumatic
- Interventions
- Other: Low Tidal Volume VentilationOther: 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
- Intracranial Pressure Monitoring device present
- Mechanically Ventilated
- Clinically Stable as determined by the Critical Care attending
- Age <14
- Prisoners
- Initial Mode of ventilation is APRV
- Provider's Judgement
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Low Tidal Volume Ventilation:LOTV Low Tidal Volume Ventilation Each 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:APRV Airway Pressure Release Ventilation Each 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
Name Time Method Intracranial Pressure On 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
Name Time Method
Trial Locations
- Locations (1)
RA Cowley Shock Trauma Center
🇺🇸Baltimore, Maryland, United States