Safety of Optimal PEEP in NSICU Patients

Not Applicable

Terminated

• Conditions: Intracranial Hypertension; Respiratory Failure
• Interventions: Device: Esophageal Balloon catheter

• Registration Number: NCT03862027
• Lead Sponsor: University of North Carolina, Chapel Hill

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 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Primary Completion: 2019-03-04
• Study Completion: 2019-03-04
• Study First Posted: 2019-03-05
• Status Verified: 2020-09
• Results First Submitted: 2021-03-05
• Results First Submitted QC: 2021-03-05
• Results First Posted: 2021-04-01
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophageal Balloon catheter	Esophageal Balloon catheter	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.

Primary Outcome Measures

Name	Time	Method
Change in ICP Value	Within 5 minutes of catheter placement	The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.

Secondary Outcome Measures

Name	Time	Method
Change in Cerebral Perfusion Pressure (CPP)	Immediately before and 5 minutes after ventilator setting change	Cerebral perfusion pressure is equal to the mean arterial pressure (MAP) minus the intracranial pressure (ICP). The initial CPP is calculated by measuring CPP immediately before changing ventilator settings. The post-intervention CPP is measured 5 minutes after ventilator setting change is made. The difference between the initial CPP and the post-intervention CPP reflects the change in CPP.
Change in Mean Arterial Pressure	Immediately before and 5 minutes after ventilator setting change	Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States