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

NCT02680704 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-02-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • M. Dustin Boone, MD · Principal Investigator

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-08-02
Completion
2018-08-02

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680704 on ClinicalTrials.gov