Clinical Trial: Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure

Brief Summary: The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).

Detailed Summary:
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: Association between PEEP and ICP [ Time Frame: Change from baseline to 20 minutes ]

Intracranial pressure will be measured and recorded using the existing intracranial pressure monitoring device placed previously as part of the patient's routine care. The association between positive end expiratory pressure and intracranial pressure will be analyzed as the primary outcome.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Association between transpulmonary pressure and ICP [ Time Frame: Change from baseline to 20 minutes ]
    Transpulmonary pressure will be measured and recorded using an esophageal balloon catheter placed for research purposes. The association between transpulmonary pressure change with titration of PEEP and intracranial pressure will be analyzed as a secondary outcome.
  • Association between PEEP and cerebral hemodynamics [ Time Frame: Change from baseline to 20 minutes ]
    Cerebral hemodynamic information will be recorded and calculated; Transcranial Doppler will be used to obtain some of this data. The association between positive end expiratory pressure and cerebral hemodynamics will be analyzed as a secondary outcome.


Original Secondary Outcome: Same as current

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: February 9, 2016
Date Started: February 2016
Date Completion:
Last Updated: April 4, 2017
Last Verified: April 2017