Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
Primary Purpose
Intracranial Hypertension, Critical Illness, Brain Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEEP titrated mechanical ventilation
Sponsored by
About this trial
This is an interventional other trial for Intracranial Hypertension
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PEEP Titration Arm
Arm Description
PEEP titrated mechanical ventilation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02680704
First Posted
February 9, 2016
Last Updated
February 20, 2019
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02680704
Brief Title
Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
Official Title
Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Departure of PI
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension, Critical Illness, Brain Injuries, Lung Injury, Respiratory Failure, Positive-Pressure Respiration, Intrinsic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEEP Titration Arm
Arm Type
Other
Arm Description
PEEP titrated mechanical ventilation
Intervention Type
Other
Intervention Name(s)
PEEP titrated mechanical ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Association between PEEP and ICP
Description
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.
Time Frame
Change from baseline to 20 minutes
Secondary Outcome Measure Information:
Title
Association between transpulmonary pressure and ICP
Description
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.
Time Frame
Change from baseline to 20 minutes
Title
Association between PEEP and cerebral hemodynamics
Description
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.
Time Frame
Change from baseline to 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Dustin Boone, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
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