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Safety of Optimal PEEP in NSICU Patients

Primary Purpose

Respiratory Failure, Intracranial Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal Balloon catheter
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esophageal Balloon catheter

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Mean Arterial Pressure
Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.

Full Information

First Posted
March 1, 2019
Last Updated
April 6, 2021
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03862027
Brief Title
Safety of Optimal PEEP in NSICU Patients
Official Title
Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Failure to enroll/recruit
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Intracranial Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esophageal Balloon catheter
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Esophageal Balloon catheter
Intervention Description
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 Measure Information:
Title
Change in ICP Value
Description
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.
Time Frame
Within 5 minutes of catheter placement
Secondary Outcome Measure Information:
Title
Change in Cerebral Perfusion Pressure (CPP)
Description
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.
Time Frame
Immediately before and 5 minutes after ventilator setting change
Title
Change in Mean Arterial Pressure
Description
Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.
Time Frame
Immediately before and 5 minutes after ventilator setting change

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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: Pneumothorax or pneumomediastinum Life expectancy < 24 hours or expected to require mechanical ventilation for < 24 hours 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). Pre-enrollment ICP > 20 mm Hg Pre-enrollment CPP < 60 mm Hg Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods Incarceration Variation in ICP of > 2 cm H2O in the hour prior to intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Carson, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Safety of Optimal PEEP in NSICU Patients

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