Obesity Clinical Trial
Official title:
Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.
Verified date | November 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 35 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin 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. Review. — View Citation
Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12. — View 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. — View Citation
Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén 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. — View 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. — View Citation
Tedjasaputra V, Sá 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | Heart ejection fraction | Difference in heart ejection fraction will be measured | Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline) |
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