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Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon (PROP OPEN)

Primary Purpose

Obesity, Morbid, Ventilator-Induced Lung Injury, Respiratory Failure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal balloon
Intervention Spontaneous Breathing Trial (SBT) and Extubation
Control Spontaneous Breathing Trial and Extubation
Intervention Weaning after Tracheostomy
Control Weaning after Tracheostomy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Transpulmonary pressure, Esophageal balloon, Esophageal pressure monitoring, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index greater than or equal to 40
  • Acute respiratory failure requiring mechanical ventilation

Exclusion Criteria:

  • Refusal to give consent by the subject or their legally authorized representative
  • Abdominal compartment syndrome
  • Chest tube for pneumothorax
  • Having been on a ventilator for >4 days
  • Suspicion of or known intracranial hypertension
  • Anticipated extubation within 24 hours
  • Chronic ventilator dependence
  • Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
  • Incarceration

Sites / Locations

  • University of North Carolina at Chapel Hill
  • East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optimal PEEP

ARDSNet High PEEP

Arm Description

The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support).

PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP.

Outcomes

Primary Outcome Measures

Number of Ventilator-Free Days (VFD) by Day 28
The number of days a patient is alive and free from the ventilator up to day 28.

Secondary Outcome Measures

Number of Patients Reintubated
Intubated within 72 hours of extubation
ICU Length of Stay
Number of days spent in the ICU
Hospital Length of Stay
Number of days spent in the Hospital
Number of Patients Receiving a Tracheostomy
Whether the patient required a tracheostomy to be liberated from the ventilator
Number of Patients Extubated Early
Extubation prior to meeting established criteria (Control group only)
Highest Richmond Agitation and Sedation Scale
Measures the mental and physical state of a sedated patient. Range from -5 to +5. A score of 0 indicates a calm arousable patient, and is the ideal score. Will capture the highest score
Lowest Richmond Agitation and Sedation Scale
Measures the mental and physical state of a sedated patient. Range from -5 to +5. A score of 0 indicates a calm arousable patient, and is the ideal score. Will capture the lowest score

Full Information

First Posted
May 13, 2019
Last Updated
November 30, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT03951064
Brief Title
Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon
Acronym
PROP OPEN
Official Title
Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

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

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
Yes

5. Study Description

Brief Summary
This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator. Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
Detailed Description
Study Design: Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/FiO2 (fraction of inspired oxygen) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm H2O.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Ventilator-Induced Lung Injury, Respiratory Failure
Keywords
Transpulmonary pressure, Esophageal balloon, Esophageal pressure monitoring, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optimal PEEP
Arm Type
Experimental
Arm Description
The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support).
Arm Title
ARDSNet High PEEP
Arm Type
Active Comparator
Arm Description
PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP.
Intervention Type
Device
Intervention Name(s)
Esophageal balloon
Intervention Description
All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be 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 - 20cm 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
Procedure
Intervention Name(s)
Intervention Spontaneous Breathing Trial (SBT) and Extubation
Intervention Description
Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP.
Intervention Type
Procedure
Intervention Name(s)
Control Spontaneous Breathing Trial and Extubation
Intervention Description
Patients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
Intervention Type
Procedure
Intervention Name(s)
Intervention Weaning after Tracheostomy
Intervention Description
Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial ONLY with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway.
Intervention Type
Procedure
Intervention Name(s)
Control Weaning after Tracheostomy
Intervention Description
The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group.
Primary Outcome Measure Information:
Title
Number of Ventilator-Free Days (VFD) by Day 28
Description
The number of days a patient is alive and free from the ventilator up to day 28.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of Patients Reintubated
Description
Intubated within 72 hours of extubation
Time Frame
72 hours after extubation
Title
ICU Length of Stay
Description
Number of days spent in the ICU
Time Frame
28 days
Title
Hospital Length of Stay
Description
Number of days spent in the Hospital
Time Frame
28 days (can capture total length after patient is discharged)
Title
Number of Patients Receiving a Tracheostomy
Description
Whether the patient required a tracheostomy to be liberated from the ventilator
Time Frame
during mechanical ventilation
Title
Number of Patients Extubated Early
Description
Extubation prior to meeting established criteria (Control group only)
Time Frame
28 days
Title
Highest Richmond Agitation and Sedation Scale
Description
Measures the mental and physical state of a sedated patient. Range from -5 to +5. A score of 0 indicates a calm arousable patient, and is the ideal score. Will capture the highest score
Time Frame
during mechanical ventilation
Title
Lowest Richmond Agitation and Sedation Scale
Description
Measures the mental and physical state of a sedated patient. Range from -5 to +5. A score of 0 indicates a calm arousable patient, and is the ideal score. Will capture the lowest score
Time Frame
during mechanical ventilation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index greater than or equal to 40 Acute respiratory failure requiring mechanical ventilation Exclusion Criteria: Refusal to give consent by the subject or their legally authorized representative Abdominal compartment syndrome Chest tube for pneumothorax Having been on a ventilator for >4 days Suspicion of or known intracranial hypertension Anticipated extubation within 24 hours Chronic ventilator dependence Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy) Incarceration
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
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A deidentified dataset will be available to investigators 9-36 months following publication of the study.
IPD Sharing Time Frame
Beginning 9 to 36 months following publication
IPD Sharing Access Criteria
Data can be obtained upon application to primary investigators. Investigators who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and execute a data use/sharing agreement with UNC.
Citations:
PubMed Identifier
30245572
Citation
Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018.
Results Reference
background
PubMed Identifier
30776290
Citation
Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
Results Reference
background

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Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

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