Safety of Optimal PEEP in NSICU Patients

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

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

Study Overview

• Status: Terminated
• Conditions: Respiratory Failure; Intracranial Hypertension
• Intervention / Treatment: Device: Esophageal Balloon catheter

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ICP Value	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.	Within 5 minutes of catheter placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cerebral Perfusion Pressure (CPP)	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.	Immediately before and 5 minutes after ventilator setting change
Change in Mean Arterial Pressure	Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.	Immediately before and 5 minutes after ventilator setting change

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Intracranial Hypertension
• Other Study ID Numbers: 18-2064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes