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

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).

Study Overview

• Status: Terminated
• Conditions: Brain Injuries; Critical Illness; Respiratory Failure; Lung Injury; Intracranial Hypertension; Positive-Pressure Respiration, Intrinsic
• Intervention / Treatment: Other: PEEP titrated mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: PEEP Titration Arm; PEEP titrated mechanical ventilation

Other: PEEP titrated mechanical ventilation; Enrolled patients will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O. Intracranial pressure, transpulmonary pressure, vitals, and mechanical ventilator data will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The mode of mechanical ventilation (pressure or volume control), inspiratory time and fraction of inspired oxygen (FIO2) will be determined by the critical care team caring for the patient. In the event that PEEP is set > 5 cmH2O, measurements will be obtained from that starting point and increased to a maximum of 15 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between PEEP and ICP	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.	Change from baseline to 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between transpulmonary pressure and ICP	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.	Change from baseline to 20 minutes
Association between PEEP and cerebral hemodynamics	Cerebral hemodynamic information will be recorded and calculated. The association between positive end expiratory pressure and cerebral hemodynamics will be analyzed as a secondary outcome.	Change from baseline to 20 minutes

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: M. Dustin Boone, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Thoracic Injuries; Brain Injuries; Respiratory Insufficiency; Wounds and Injuries; Critical Illness; Lung Injury; Intracranial Hypertension; Positive-Pressure Respiration, Intrinsic
• Other Study ID Numbers: 2015P000089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No