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

NCT ID: NCT02680704

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-08-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PEEP Titration Arm

PEEP titrated mechanical ventilation

Group Type: OTHER

PEEP titrated mechanical ventilation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Valerie Banner-Goodspeed

Clinical Research Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M. Dustin Boone, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000089

Identifier Type: -

Identifier Source: org_study_id