UnknownNot Applicable

Effects of PEEP on Heart and Lungs in Obese Subjects

United States35 participantsStarted 2018-04-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

End Expiratory Lung Volume

Timeframe: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)

Trial details

NCT IDNCT02523352

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

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