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The Brain and Lung Interaction (BALI) Study

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ClinicalTrials.gov Identifier: NCT04288076
Recruitment Status : Withdrawn (Low eligibility rate)
First Posted : February 27, 2020
Last Update Posted : January 27, 2021
Information provided by (Responsible Party):
Shahzad Shaefi, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Mechanical Ventilation Brain Injuries Other: PEEP Titrated Mechanical Ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Positive End Expiratory Pressure on Intracranial Pressure: The Brain and Lung Interaction (BALI) Study
Estimated Study Start Date : September 2020
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020

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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Shahzad Shaefi, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04288076    
Other Study ID Numbers: 2019P000830
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries