The Brain and Lung Interaction (BALI) Study

January 25, 2021 updated by: Shahzad Shaefi, Beth Israel Deaconess Medical Center

The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study

The purpose of this study is to understand the relationship between intracranial pressure and airway pressures during mechanical ventilation. This study is a single-center, prospective cohort study to be conducted at Beth Israel Deaconess Medical Center. The investigators will recruit patients with severe brain injury (GCS 8 or less) who receive intracranial pressure monitoring and mechanical ventilation as part of their routine medical care. The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure. There is only one study encounter with safety monitoring for up to 24 hours after. No additional follow up is required.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients with severe brain injury (GCS 8 or less) who receive both mechanical ventilation and intracranial pressure monitoring as part of their standard medical care will be considered eligible.

Exclusion Criteria:

  • Patients with esophageal varices
  • Patients with esophageal trauma
  • Patients with recent esophageal surgery
  • Patients with coagulopathy (Platelets < 80k or INR> 2 )
  • Other contraindication for esophageal manometry
  • Patients who are receiving PEEP greater than 15 cmH2O within 24 hours prior to enrollment
  • Intracranial hypertension (defined as ICP greater than 20 mmHg) within 48 hours prior to enrollment
  • Decompressive hemi-craniectomy

Cessation Criteria: Study related ventilator adjustments and measurements will be stopped at any point during the intervention and ventilator settings will be returned to the pre-intervention settings under the following conditions:

  • If ICP increases above 20mmHg, regardless of the duration of the event.
  • If systolic blood pressure decreases below 90mmHg, regardless of the duration of the event.
  • If systolic blood pressure increases above 180mmHg, regardless of the duration of the event.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEEP Titration Arm
Other: PEEP Titrated Mechanical Ventilation
Subjects will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O and back down to 5 cmH20. Pleural pressure and intracranial pressure will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period. 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. At the completion of the study patients will be returned to the PEEP level they were on prior to titration of the ventilator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intracranial pressure
Time Frame: Change from baseline to 20 minutes
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Change from baseline to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ACTUAL)

October 15, 2020

Study Completion (ACTUAL)

October 15, 2020

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P000830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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