Effects of PEEP on Heart and Lungs in Obese Subjects

November 16, 2020 updated by: Robert M. Kacmarek, Massachusetts General Hospital

Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Volunteers with a BMI > 35 Kg/m2 and central fat distribution, without any past medical history
Procedure: Non-Invasive Ventilation
Progressive increase in airway pressure to open lungs atelectatic regions.
Procedure: Esophageal catheter positioning
The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End Expiratory Lung Volume
Time Frame: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Difference in end expiratory lung volume measured in mL
Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work of breathing
Time Frame: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Difference in work of breathing will be measured as Joule/min
Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Right heart volumes
Time Frame: Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
Difference in right heart and diastolic and end systolic volumes will be measured
Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
Heart ejection fraction
Time Frame: Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
Difference in heart ejection fraction will be measured
Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Robert Kacmarek, RRT, PhD, Massachussets General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT-TTE-MRI-Obese

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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