Safety of Optimal PEEP in NSICU Patients

University of North Carolina (UNC)

Status: Terminated

Conditions: Respiratory Failure; Intracranial Hypertension

Treatments: Device: Esophageal Balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03862027

18-2064

Details and patient eligibility

About

The investigators aim to demonstrate that use of transpulmonary pressure to guide PEEP management is safe in patients with possible elevations of intracranial pressure.

Full 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.

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (age >/= 18) admitted to the Neuro ICU of UNC Hospital requiring mechanical ventilation and with ICP monitoring in place.

Exclusion criteria

1. Pneumothorax or pneumomediastinum
2. Life expectancy < 24 hours or expected to require mechanical ventilation for < 24 hours
3. 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).
4. Pre-enrollment ICP > 20 mm Hg
5. Pre-enrollment CPP < 60 mm Hg
6. Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods
7. Incarceration
8. Variation in ICP of > 2 cm H2O in the hour prior to intervention.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Esophageal Balloon catheter

Experimental group

Description:

All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed \> 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.

Treatment:

Device: Esophageal Balloon catheter