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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02680704
• Other study ID #: 2015P000089
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: August 2, 2018

Study information

• Verified date: February 2019
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Critical Illness
• Intracranial Hypertension
• Lung Injury
• Positive-Pressure Respiration, Intrinsic
• Respiratory Failure
• Respiratory Insufficiency
• Wounds and Injuries

Intervention

Other:
• PEEP titrated mechanical ventilation
Enrolled patients will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O. Intracranial pressure, transpulmonary pressure, vitals, and mechanical ventilator data will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. 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. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between PEEP and ICP	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.	Change from baseline to 20 minutes
Secondary	Association between transpulmonary pressure and ICP	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.	Change from baseline to 20 minutes
Secondary	Association between PEEP and cerebral hemodynamics	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.	Change from baseline to 20 minutes