The Brain and Lung Interaction (BALI) Study

Not Applicable

Withdrawn

• Conditions: Intracranial Pressure; Brain Injuries; Mechanical Ventilation
• Interventions: Other: PEEP Titrated Mechanical Ventilation

• Registration Number: NCT04288076
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Study Start: 2020-09
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEP Titration Arm	PEEP Titrated Mechanical Ventilation	-

Primary Outcome Measures

Name	Time	Method
Change in intracranial pressure	Change from baseline to 20 minutes	The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.