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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02680704

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hypertension Critical Illness Brain Injuries Lung Injury Respiratory Failure Positive-Pressure Respiration, Intrinsic	Other: PEEP titrated mechanical ventilation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Aug 2, 2018

Actual Study Completion Date :

Aug 2, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Association between PEEP and ICP [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 Outcome Measures

Association between transpulmonary pressure and ICP [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 [Change from baseline to 20 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator: M. Dustin Boone, MD, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Valerie Banner-Goodspeed, Clinical Research Administrator, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT02680704

Other Study ID Numbers:

2015P000089

First Posted:

Feb 11, 2016

Last Update Posted:

Feb 22, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Respiratory Insufficiency

Lung Injury

Positive-Pressure Respiration, Intrinsic

Brain Injuries

Intracranial Hypertension

Critical Illness

Wounds and Injuries

Study Results

No Results Posted as of Feb 22, 2019