The Brain and Lung Interaction (BALI) Study

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Brain Injuries; Intracranial Pressure; Mechanical Ventilation

Treatments: Other: PEEP Titrated Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04288076

2019P000830

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PEEP Titration Arm

Experimental group

Treatment:

Other: PEEP Titrated Mechanical Ventilation