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Effects of PEEP on Heart and Lungs in Obese Subjects

Primary Purpose

Obesity, Pulmonary Atelectasis, Obesity Hypoventilation Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Invasive Ventilation
Esophageal catheter positioning
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have a photo identification document
  • BMI ≥ 35 kg/m2
  • Waist circumference > 88 cm (for women)
  • Waist circumference > 102 cm (for men)

Exclusion Criteria:

  • Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
  • Subjects with any known condition, including claustrophobia or pain, which limits their ability to lie in the MR scanner for the duration of the research study
  • Known presence of esophageal varices
  • Recent esophageal trauma or surgery
  • Known Coagulopathy
  • History of pneumothorax
  • Pregnancy
  • Diabetes
  • Presence of prosthesis incompatible with MR
  • Thoracic diameter grater than 70 cm
  • Resting heart rate (HR) < 50 or > 120 bpm and/or systolic blood pressure < 90 or > 160 mmHg and/or peripheral oxygen saturation (SpO2) < 88%
  • Currently enrolled in another research study

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Volunteers with a BMI > 35 Kg/m2 and central fat distribution, without any past medical history

Outcomes

Primary Outcome Measures

End Expiratory Lung Volume
Difference in end expiratory lung volume measured in mL

Secondary Outcome Measures

Work of breathing
Difference in work of breathing will be measured as Joule/min
Right heart volumes
Difference in right heart and diastolic and end systolic volumes will be measured
Heart ejection fraction
Difference in heart ejection fraction will be measured

Full Information

First Posted
August 10, 2015
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02523352
Brief Title
Effects of PEEP on Heart and Lungs in Obese Subjects
Official Title
Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of this study is to better understand pathophysiology of the alteration of respiratory mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to test this hypothesis with a physiological, interventional study conducted on volunteers by using Electrical Impedance Tomography in a group of patients and magnetic resonance imaging (MRI) in another group.
Detailed Description
Obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. The investigators do believe that the respiratory system derangements observed in the previous study during the critical illness are already present, although in lower severity, in the obese patients in their basal condition. This study will help to understand the standard cardiac and respiratory function of an obese non critically ill subject to better target the therapies during the management of the critical illness to reestablish the homeostasis of the system: The investigator's hypotheses are: To demonstrate if morbidly obese patients show atelectasis at spontaneous breathing in the supine position and whether the increase in lung volume following PEEP titration is due to alveolar recruitment rather than overdistention. To measure regional variations in ventilation/perfusion coupling at different ventilator settings To investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure To test if reopening of lung atelectasis through the application o a recruitment maneuver and titrated PEEP level would lead to an improvement in right heart function. To assess pulmonary circulation at different levels of PEEP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pulmonary Atelectasis, Obesity Hypoventilation Syndrome, Magnetic Resonance Imaging, Respiratory Mechanics, Electrical Impedance Tomography, Trans-Thoracic Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
35 patients will be enrolled in this study. The study is divided in two phases: the first phase will evaluate the PEEP in 12 consecutive obese subjects and 6 healthy volunteers using Trans-thoracic echocardiography (TTE) and Electrical Impedance Tomography (EIT). The second phase will evaluate the PEEP in the other 12 consecutive obese subjects and 5 healthy volunteers using Magnetic Resonance Imaging (MRI).
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Volunteers with a BMI > 35 Kg/m2 and central fat distribution, without any past medical history
Intervention Type
Procedure
Intervention Name(s)
Non-Invasive Ventilation
Intervention Description
Progressive increase in airway pressure to open lungs atelectatic regions.
Intervention Type
Procedure
Intervention Name(s)
Esophageal catheter positioning
Intervention Description
The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia
Primary Outcome Measure Information:
Title
End Expiratory Lung Volume
Description
Difference in end expiratory lung volume measured in mL
Time Frame
Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Secondary Outcome Measure Information:
Title
Work of breathing
Description
Difference in work of breathing will be measured as Joule/min
Time Frame
Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Title
Right heart volumes
Description
Difference in right heart and diastolic and end systolic volumes will be measured
Time Frame
Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
Title
Heart ejection fraction
Description
Difference in heart ejection fraction will be measured
Time Frame
Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have a photo identification document BMI ≥ 35 kg/m2 Waist circumference > 88 cm (for women) Waist circumference > 102 cm (for men) Exclusion Criteria: Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year Subjects with any known condition, including claustrophobia or pain, which limits their ability to lie in the MR scanner for the duration of the research study Known presence of esophageal varices Recent esophageal trauma or surgery Known Coagulopathy History of pneumothorax Pregnancy Diabetes Presence of prosthesis incompatible with MR Thoracic diameter grater than 70 cm Resting heart rate (HR) < 50 or > 120 bpm and/or systolic blood pressure < 90 or > 160 mmHg and/or peripheral oxygen saturation (SpO2) < 88% Currently enrolled in another research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kacmarek, RRT, PhD
Organizational Affiliation
Massachussets 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
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19910329
Citation
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Results Reference
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PubMed Identifier
21868467
Citation
Chahal H, McClelland RL, Tandri H, Jain A, Turkbey EB, Hundley WG, Barr RG, Kizer J, Lima JAC, Bluemke DA, Kawut SM. Obesity and right ventricular structure and function: the MESA-Right Ventricle Study. Chest. 2012 Feb;141(2):388-395. doi: 10.1378/chest.11-0172. Epub 2011 Aug 25.
Results Reference
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PubMed Identifier
24736287
Citation
Steier J, Lunt A, Hart N, Polkey MI, Moxham J. Observational study of the effect of obesity on lung volumes. Thorax. 2014 Aug;69(8):752-9. doi: 10.1136/thoraxjnl-2014-205148. Epub 2014 Apr 15.
Results Reference
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PubMed Identifier
23640585
Citation
Tedjasaputra V, Sa RC, Arai TJ, Holverda S, Theilmann RJ, Chen WT, Wagner PD, Davis CK, Kim Prisk G, Hopkins SR. The heterogeneity of regional specific ventilation is unchanged following heavy exercise in athletes. J Appl Physiol (1985). 2013 Jul 1;115(1):126-35. doi: 10.1152/japplphysiol.00778.2012. Epub 2013 May 2.
Results Reference
background
PubMed Identifier
24467647
Citation
Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
Results Reference
background
PubMed Identifier
19809292
Citation
Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
Results Reference
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PubMed Identifier
34099131
Citation
Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016/j.chest.2021.01.055. Epub 2021 May 8.
Results Reference
derived

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Effects of PEEP on Heart and Lungs in Obese Subjects

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