Status:
TERMINATED
Safety of Optimal PEEP in NSICU Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Respiratory Failure
Intracranial Hypertension
Eligibility:
All Genders
Phase:
NA
Brief Summary
The investigators aim to demonstrate that use of transpulmonary pressure to guide PEEP management is safe in patients with possible elevations of intracranial pressure.
Detailed Description
Purpose: To establish safety of titrating PEEP based on transpulmonary pressure as measured by an esophageal balloon in mechanically ventilated neurosurgical patients. Participants: Adult patients ad...
Eligibility Criteria
Inclusion
- Adult patients (age \>/= 18) admitted to the Neuro ICU of UNC Hospital requiring mechanical ventilation and with ICP monitoring in place.
Exclusion
- Pneumothorax or pneumomediastinum
- Life expectancy \< 24 hours or expected to require mechanical ventilation for \< 24 hours
- Condition that precludes placement of an esophageal balloon \[esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter (esophageal ulcerations, tumors, diverticulitis, bleeding varices or in patients with sinusitis, epistaxis or recent nasopharyngeal surgery), severe thrombocytopenia (platelet count \< 30) or coagulopathy (INR \> 3 or on oral anticoagulants).
- Pre-enrollment ICP \> 20 mm Hg
- Pre-enrollment CPP \< 60 mm Hg
- Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods
- Incarceration
- Variation in ICP of \> 2 cm H2O in the hour prior to intervention.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03862027
Start Date
March 1 2019
End Date
March 4 2019
Last Update
April 27 2021
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599