Effects of PEEP on Heart and Lungs in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02523352
• Other study ID #: EIT-TTE-MRI-Obese
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Non-Invasive Ventilation
Progressive increase in airway pressure to open lungs atelectatic regions.
• Esophageal catheter positioning
The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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)