Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure

Not Applicable

Terminated

• Conditions: Critical Illness; Positive-Pressure Respiration, Intrinsic; Brain Injuries; Respiratory Failure; Intracranial Hypertension; Lung Injury
• Interventions: Other: PEEP titrated mechanical ventilation

• Registration Number: NCT02680704
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-11
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients with severe brain injury (GCS 8 or less)
• Receiving mechanical ventilation
• Receiving intracranial pressure monitoring

Exclusion Criteria

• Esophageal varices
• Esophageal trauma
• Recent esophageal surgery
• Coagulopathy (Platelets < 80k or INR> 2 )
• Other contraindication for esophageal manometry
• Already receiving PEEP > 15 cmH2O at enrollment
• Intracranial hypertension (defined as ICP > 20 mmHg)
• Decompressive hemi-craniectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEP Titration Arm	PEEP titrated mechanical ventilation	PEEP titrated mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Association between PEEP and ICP	Change from baseline to 20 minutes	Intracranial pressure will be measured and recorded using the existing intracranial pressure monitoring device placed previously as part of the patient's routine care. The association between positive end expiratory pressure and intracranial pressure will be analyzed as the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Association between transpulmonary pressure and ICP	Change from baseline to 20 minutes	Transpulmonary pressure will be measured and recorded using an esophageal balloon catheter placed for research purposes. The association between transpulmonary pressure change with titration of PEEP and intracranial pressure will be analyzed as a secondary outcome.
Association between PEEP and cerebral hemodynamics	Change from baseline to 20 minutes	Cerebral hemodynamic information will be recorded and calculated. The association between positive end expiratory pressure and cerebral hemodynamics will be analyzed as a secondary outcome.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States