NCT03862027

Safety of Optimal PEEP in NSICU Patients

Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 admitted to the Neuro ICU at UNC Hospital and requiring mechanical ventilation who have an intracranial pressure monitoring device in place. Procedures (methods): All enrolled patients will have esophageal balloons placed with measurement of transpulmonary pressures. All patients will have baseline measurements recorded of intracranial pressure, cerebral perfusion pressure, and cerebral autoregulation. PEEP will then be titrated based on transpulmonary pressure measurements with recording of physiological measurements over the next hour. At the conclusion of the hour, all patients will be returned to their prior ventilator settings.

Conditions

• Respiratory Failure
• Intracranial Hypertension

Interventions

Type	Name	Description
DEVICE	Esophageal Balloon catheter	Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-03-04
• Completion: 2019-03-04
• First posted: 2019-03-05
• Last updated: 2021-04-27
• Results posted: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study