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出境医 / 临床实验 / Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon (PROP OPEN)

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

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Ventilator-Induced Lung Injury Respiratory Failure Device: Esophageal balloon Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation Procedure: Control Spontaneous Breathing Trial and Extubation Procedure: Intervention Weaning after Tracheostomy Procedure: Control Weaning after Tracheostomy Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Optimal PEEP
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).
 Device: Esophageal balloon
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.

Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation
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.

Procedure: Intervention Weaning after Tracheostomy
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.
Active Comparator: ARDSNet High PEEP
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.
 Device: Esophageal balloon
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.

Procedure: Control Spontaneous Breathing Trial and Extubation
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.

Procedure: Control Weaning after Tracheostomy
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.
Outcome Measures
Primary Outcome Measures :
  1. Number of Ventilator-Free Days (VFD) by Day 28 [ Time Frame: 28 days ]
    The number of days a patient is alive and free from the ventilator up to day 28.


Secondary Outcome Measures :
  1. Number of Patients Reintubated [ Time Frame: 72 hours after extubation ]
    Intubated within 72 hours of extubation

  2. ICU Length of Stay [ Time Frame: 28 days ]
    Number of days spent in the ICU

  3. Hospital Length of Stay [ Time Frame: 28 days (can capture total length after patient is discharged) ]
    Number of days spent in the Hospital

  4. Number of Patients Receiving a Tracheostomy [ Time Frame: during mechanical ventilation ]
    Whether the patient required a tracheostomy to be liberated from the ventilator

  5. Number of Patients Extubated Early [ Time Frame: 28 days ]
    Extubation prior to meeting established criteria (Control group only)

  6. Highest Richmond Agitation and Sedation Scale [ Time Frame: during mechanical ventilation ]

    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


  7. Lowest Richmond Agitation and Sedation Scale [ Time Frame: during mechanical ventilation ]

    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



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
University of North Carolina, Chapel Hill
East Carolina University
Investigators
Layout table for investigator information
Principal Investigator: Thomas Bice, MD University of North Carolina, Chapel Hill
Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date March 1, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2020) 		Number of Ventilator-Free Days (VFD) by Day 28 [ Time Frame: 28 days ]
The number of days a patient is alive and free from the ventilator up to day 28.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019) 		Ventilator-free days (VFD) by day 28 [ Time Frame: 28 days ]
The number of days a patient is alive and free from the ventilator up to day 28.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Number of Patients Reintubated [ Time Frame: 72 hours after extubation ]
    Intubated within 72 hours of extubation
  • ICU Length of Stay [ Time Frame: 28 days ]
    Number of days spent in the ICU
  • Hospital Length of Stay [ Time Frame: 28 days (can capture total length after patient is discharged) ]
    Number of days spent in the Hospital
  • Number of Patients Receiving a Tracheostomy [ Time Frame: during mechanical ventilation ]
    Whether the patient required a tracheostomy to be liberated from the ventilator
  • Number of Patients Extubated Early [ Time Frame: 28 days ]
    Extubation prior to meeting established criteria (Control group only)
  • Highest Richmond Agitation and Sedation Scale [ Time Frame: during mechanical ventilation ]
    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 [ Time Frame: during mechanical ventilation ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Reintubation [ Time Frame: 72 hours after extubation ]
    Intubated within 72 hours of extubation
  • ICU Length of Stay [ Time Frame: 28 days ]
    Number of days spent in the ICU
  • Hospital Length of Stay [ Time Frame: 28 days (can capture total length after patient is discharged) ]
    Number of days spent in the Hospital
  • Tracheostomy [ Time Frame: during mechanical ventilation ]
    Whether the patient required a tracheostomy to be liberated from the ventilator
  • Early Extubation [ Time Frame: 28 days ]
    Extubation prior to meeting established criteria (Control group only)
  • Highest RASS [ Time Frame: during mechanical ventilation ]
    Single highest score on the Richmond Agitation and Sedation Scale
  • Lowest RASS [ Time Frame: during mechanical ventilation ]
    Single lowest score on the Richmond Agitation and Sedation Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon
Official Title  ICMJE Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity, Morbid
  • Ventilator-Induced Lung Injury
  • Respiratory Failure
Intervention  ICMJE
  • Device: Esophageal balloon
    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.
  • Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation
    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.
  • Procedure: Control Spontaneous Breathing Trial and Extubation
    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.
  • Procedure: Intervention Weaning after Tracheostomy
    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.
  • Procedure: Control Weaning after Tracheostomy
    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.
Study Arms  ICMJE
  • Experimental: Optimal PEEP
    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).
    Interventions:
    • Device: Esophageal balloon
    • Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation
    • Procedure: Intervention Weaning after Tracheostomy
  • Active Comparator: ARDSNet High PEEP
    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.
    Interventions:
    • Device: Esophageal balloon
    • Procedure: Control Spontaneous Breathing Trial and Extubation
    • Procedure: Control Weaning after Tracheostomy
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951064
Other Study ID Numbers  ICMJE 18-2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 9 to 36 months following publication
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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE East Carolina University
Investigators  ICMJE
Principal Investigator: Thomas Bice, MD University of North Carolina, Chapel Hill
Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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