Status:
WITHDRAWN
The Brain and Lung Interaction (BALI) Study
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Intracranial Pressure
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04288076
Start Date
September 1 2020
End Date
October 15 2020
Last Update
January 27 2021
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