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

Overview

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.

Full Title of Study: “Study of APRV and ICP in Patients With Severe Traumatic Brain Injury”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2018

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.

Interventions

  • Other: Airway Pressure Release Ventilation
    • Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.
  • Other: Low Tidal Volume Ventilation
    • After enrollment and collection of baseline Intracranial pressure and hemodynamic status for 30 minutes the participants will undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation. LOTV is most commonly used for trauma patients with lung injury. LOTV provides oxygen in smaller amounts, without overstretching the lungs

Arms, Groups and Cohorts

  • Airway Pressure Release Ventilation:APRV
    • 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.
  • Low Tidal Volume Ventilation:LOTV
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Intracranial Pressure
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Maryland, Baltimore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Deborah Stein, Medical Director, Neurotrauma Critical Care; Chief, Section of Trauma Critical Care, R Adams Cowley Shock Trauma Center – University of Maryland, Baltimore
  • Overall Official(s)
    • Deborah M Stein, MD, MPH, Principal Investigator, Professor, Department of Surgery

References

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