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

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ClinicalTrials.gov Identifier: NCT03862027
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Bice, MD, MSc, University of North Carolina, Chapel Hill

Brief Summary:
We 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)
Estimated Enrollment : 25 participants
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 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 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03862027


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Thomas Bice, MD    919-966-2531    thomas_bice@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill

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Responsible Party: Thomas Bice, MD, MSc, Assistant Professor of Pulmonary and Critical Care MEdicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03862027     History of Changes
Other Study ID Numbers: 18-2064
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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