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

Beth Israel Deaconess Medical Center1 site in 1 country4 target enrollmentFebruary 2016

ConditionsIntracranial Hypertension Critical Illness Brain Injuries Lung Injury Respiratory Failure Positive-Pressure Respiration, Intrinsic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Hypertension
Sponsor: Beth Israel Deaconess Medical Center
Enrollment: 4
Locations: 1
Primary Endpoint: Association between PEEP and ICP
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

August 2, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beth Israel Deaconess Medical Center

Responsible Party

Principal Investigator

Valerie Banner-Goodspeed

Clinical Research Administrator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

•Patients with severe brain injury (GCS 8 or less)
•Receiving mechanical ventilation
•Receiving intracranial pressure monitoring

Exclusion Criteria

•Esophageal varices
•Esophageal trauma
•Recent esophageal surgery
•Coagulopathy (Platelets \< 80k or INR\> 2 )
•Other contraindication for esophageal manometry
•Already receiving PEEP \> 15 cmH2O at enrollment
•Intracranial hypertension (defined as ICP \> 20 mmHg)
•Decompressive hemi-craniectomy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Association between transpulmonary pressure and ICP(Change from baseline to 20 minutes)
Association between PEEP and cerebral hemodynamics(Change from baseline to 20 minutes)