Effects of PEEP on Heart and Lungs in Obese Subjects
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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.
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To measure regional variations in ventilation/perfusion coupling at different ventilator settings
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To investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure
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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.
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To assess pulmonary circulation at different levels of PEEP.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- End Expiratory Lung Volume [Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)]
Difference in end expiratory lung volume measured in mL
Secondary Outcome Measures
- Work of breathing [Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)]
Difference in work of breathing will be measured as Joule/min
- Right heart volumes [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
- Heart ejection fraction [Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)]
Difference in heart ejection fraction will be measured
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a photo identification document
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BMI ≥ 35 kg/m2
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Waist circumference > 88 cm (for women)
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Waist circumference > 102 cm (for men)
Exclusion Criteria:
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Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
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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
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Known presence of esophageal varices
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Recent esophageal trauma or surgery
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Known Coagulopathy
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History of pneumothorax
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Pregnancy
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Diabetes
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Presence of prosthesis incompatible with MR
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Thoracic diameter grater than 70 cm
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Resting heart rate (HR) < 50 or > 120 bpm and/or systolic blood pressure < 90 or > 160 mmHg and/or peripheral oxygen saturation (SpO2) < 88%
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Currently enrolled in another research study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Robert Kacmarek, RRT, PhD, Massachussets General Hospital
- Principal Investigator: Lorenzo Berra, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- EIT-TTE-MRI-Obese