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

NCT02680704 | Terminated DMC

• 1 other identifier: 2015P000089
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Association between transpulmonary pressure and ICP

  Change from baseline to 20 minutes

• Association between PEEP and cerebral hemodynamics

  Change from baseline to 20 minutes

Study Arms (1)

PEEP Titration Arm

OTHER

PEEP titrated mechanical ventilation

Other: PEEP titrated mechanical ventilation

Interventions

PEEP titrated mechanical ventilation OTHER

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.

PEEP Titration Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Intracranial Hypertension; Critical Illness; Brain Injuries; Lung Injury; Respiratory Insufficiency; Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Respiration Disorders

Study Officials

• M. Dustin Boone, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Administrator

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 11, 2016
• Study Start: February 1, 2016
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)