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Safety of Optimal PEEP in NSICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03862027
Recruitment Status : Terminated (Failure to enroll/recruit)
First Posted : March 5, 2019
Results First Posted : April 1, 2021
Last Update Posted : April 27, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Intracranial Hypertension Device: Esophageal Balloon catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : March 4, 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Change in ICP Value [ Time Frame: 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 :
  1. Change in Cerebral Perfusion Pressure (CPP) [ Time Frame: 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.

  2. Change in Mean Arterial Pressure [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03862027

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT03862027    
Other Study ID Numbers: 18-2064
First Posted: March 5, 2019    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: April 27, 2021
Last Verified: September 2020

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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
Additional relevant MeSH terms:
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Respiratory Insufficiency
Intracranial Hypertension
Respiration Disorders
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases