Effects of PEEP on Heart and Lungs in Obese Subjects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Pulmonary Atelectasis, Obesity Hypoventilation Syndrome, Magnetic Resonance Imaging, Respiratory Mechanics, Electrical Impedance Tomography, Trans-Thoracic Echocardiography

Intervention / Treatment
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* Procedure: Non-Invasive Ventilation
* Procedure: Esophageal catheter positioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Expiratory Lung Volume | 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 | 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 | 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 | Difference in heart ejection fraction will be measured | Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline) |