Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02507973


Primary Contact:

Principal Investigator
Deborah M Stein, MD, MPH
Professor, Department of Surgery

Cherisse D Berry, MD
Phone: 3106214728
Email: cberry@umm.edu


Backup Contact:

Email: claire.rosen@som.umaryland.edu
Claire B Rosen, BA
Phone: 4438677328


Location Contact:

Baltimore, Maryland 21201
United States

Deborah Stein, MD, MPH
Phone: 443-328-3495
Email: dstein@umm.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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