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Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive end-expiratory pressure (PEEP)
ZEEP
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Mechanical ventilation, Positive end-expiratory pressure, Work of breathing, Morbidly obese

Eligibility Criteria

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

Inclusion Criteria:

  • Intubated and mechanically ventilated;
  • Weaning from mechanical ventilation;
  • BMI ≥ 35 kg/m2 with waist circumference > 88 cm for women; waist circumference > 102 cm for men.
  • A well functioning arterial line.

Exclusion Criteria:

  • Known presence of esophageal varices
  • Recent esophageal trauma or surgery
  • Severe thrombocytopenia (PTL ≤ 5,000/mm3)
  • Severe coagulopathy (INR ≥ 4)
  • Presence of pneumothorax
  • Pregnancy
  • Pacemaker and/or internal cardiac defibrillator

Sites / Locations

  • Massachussets General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with BMI > 35

Arm Description

ICU patients with a BMI > 35, on pressure support ventilation, scheduled for spontaneous breathing trial for evaluation of extubation After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs) in randomized order. Either the patient will receive SBT at PEEP = 0-5 cmH2O, with PSV=0 and FiO2 unchanged; or the patient will perform an SBT at "Titrated-PEEP", with the PSV=0 and FiO2 unchanged.

Outcomes

Primary Outcome Measures

Differences in WOB at titrated PEEP levels vs. ZEEP level
Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at titrated PEEP vs. Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at zero PEEP

Secondary Outcome Measures

Gas Exchange - Oxygenation
Difference in oxygenation as measured in mmHg of PaO2/FiO2 during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Gas Exchange - Arterial carbon dioxide
Difference in arterial carbon dioxide as measured in mmHg (PaCO2) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Respiratory Mechanics - Compliance
Difference in Compliance, measured as ml/cmH2O, of the respiratory system, lungs and chest wall during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Gas Volume Distribution
Difference in the images of Electric Impedance Tomography measured as relative variation of regional impedance (deltaZ) (i.e. distribution of ventilation) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Hemodynamics - Blood pressure
Changes in arterial blood pressures (BP, mmHg) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Hemodynamics - Heart rate
Changes in heart rate (HR, bpm) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.

Full Information

First Posted
June 12, 2015
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02492113
Brief Title
Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation
Official Title
Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to define at the bedside the "Titrated-PEEP" level for obese patients that increases the likelihood of extubation and ventilator liberation. The investigators hypothesized that a titrated level of PEEP ("Titrated-PEEP") during SBT will keep the lung recruited, maintain oxygenation, and decrease the work of breathing resulting in successful ventilator liberation. In addition, post-extubation the investigators hypothesize that these patients will require noninvasive ventilatory support in the form of CPAP at the level of "titrated-PEEP" used during the SBT.
Detailed Description
The high WOB of morbidly obese patients is associated with respiratory muscle fatigue and failure in extubation. The investigators hypothesized that the use of a titrated PEEP level prior to and after extubation might improve successful extubation rates and avoid re-intubation. In this study, patients will be awake and ventilated in the pressure support ventilation (PSV) mode. The investigators will apply different PEEP levels to measure WOB, transpulmonary pressure and characterize the response of the respiratory system to increasing or decreasing PEEP. The "Titrated-PEEP" will be identified as the PEEP level associated with the lowest value of respiratory system elastance and an end expiratory transpulmonary pressure of 2 cmH2O. Then the participants will have two spontaneous breathing trials; one at PEEP 0-5 cmH2O, and the other at the "Titrated-PEEP" level, with PSV=0 and FiO2 unchanged. After extubation, the participants will first receive CPAP set at "Titrated-PEEP", then spontaneous breathing. Electrical impedance tomography (EIT), respiratory system mechanics and gas exchange will be recorded during the study. The investigators believe that the real-time determination of "Titrated-PEEP" can guide the treatment of mechanical ventilation and give us a better understanding of the physiology and pathophysiology of morbidly obese patients. As a result, this study will improve patient safety; reduce the duration of mechanical ventilation, complications and healthcare costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Mechanical ventilation, Positive end-expiratory pressure, Work of breathing, Morbidly obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with BMI > 35
Arm Type
Experimental
Arm Description
ICU patients with a BMI > 35, on pressure support ventilation, scheduled for spontaneous breathing trial for evaluation of extubation After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs) in randomized order. Either the patient will receive SBT at PEEP = 0-5 cmH2O, with PSV=0 and FiO2 unchanged; or the patient will perform an SBT at "Titrated-PEEP", with the PSV=0 and FiO2 unchanged.
Intervention Type
Procedure
Intervention Name(s)
Positive end-expiratory pressure (PEEP)
Intervention Description
"Titrated-PEEP". After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at "Titrated-PEEP", with the PSV=0 and FiO2 unchanged.
Intervention Type
Procedure
Intervention Name(s)
ZEEP
Intervention Description
After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at PEEP = 0-5 cmH2O, with the PSV=0 and FiO2 unchanged.
Primary Outcome Measure Information:
Title
Differences in WOB at titrated PEEP levels vs. ZEEP level
Description
Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at titrated PEEP vs. Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at zero PEEP
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Gas Exchange - Oxygenation
Description
Difference in oxygenation as measured in mmHg of PaO2/FiO2 during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours
Title
Gas Exchange - Arterial carbon dioxide
Description
Difference in arterial carbon dioxide as measured in mmHg (PaCO2) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours
Title
Respiratory Mechanics - Compliance
Description
Difference in Compliance, measured as ml/cmH2O, of the respiratory system, lungs and chest wall during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours
Title
Gas Volume Distribution
Description
Difference in the images of Electric Impedance Tomography measured as relative variation of regional impedance (deltaZ) (i.e. distribution of ventilation) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours
Title
Hemodynamics - Blood pressure
Description
Changes in arterial blood pressures (BP, mmHg) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours
Title
Hemodynamics - Heart rate
Description
Changes in heart rate (HR, bpm) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated and mechanically ventilated; Weaning from mechanical ventilation; BMI ≥ 35 kg/m2 with waist circumference > 88 cm for women; waist circumference > 102 cm for men. A well functioning arterial line. Exclusion Criteria: Known presence of esophageal varices Recent esophageal trauma or surgery Severe thrombocytopenia (PTL ≤ 5,000/mm3) Severe coagulopathy (INR ≥ 4) Presence of pneumothorax Pregnancy Pacemaker and/or internal cardiac defibrillator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenzo Berra, MD
Phone
6176437733
Email
lberra@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kacmarek, RRT, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorenzo Berra, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachussets General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Berra
Phone
617-643-7733

12. IPD Sharing Statement

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Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

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