Effects of PEEP on Heart and Lungs in Obese Subjects

NCT02523352 | Unknown

• 1 other identifier: EIT-TTE-MRI-Obese
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Work of breathing

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

• Right heart volumes

  Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)

• Heart ejection fraction

  Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)

Study Arms (1)

Treatment

EXPERIMENTAL

Volunteers with a BMI \> 35 Kg/m2 and central fat distribution, without any past medical history

Procedure: Non-Invasive Ventilation; Procedure: Esophageal catheter positioning

Interventions

Non-Invasive Ventilation PROCEDURE

Progressive increase in airway pressure to open lungs atelectatic regions.

Treatment

Esophageal catheter positioning PROCEDURE

The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a photo identification document
• BMI ≥ 35 kg/m2
• Waist circumference \> 88 cm (for women)
• Waist circumference \> 102 cm (for men)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

• 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.

  PMID: 19910329 BACKGROUND

• 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.

  PMID: 21868467 BACKGROUND

• 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.

  PMID: 24736287 BACKGROUND

• Tedjasaputra V, Sa 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.

  PMID: 23640585 BACKGROUND

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin 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.

  PMID: 24467647 BACKGROUND

• Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden 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.

  PMID: 19809292 BACKGROUND

• Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016/j.chest.2021.01.055. Epub 2021 May 8.

  PMID: 34099131 DERIVED

MeSH Terms

Conditions

Obesity; Pulmonary Atelectasis; Obesity Hypoventilation Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Robert Kacmarek, RRT, PhD

  Massachussets General Hospital

  PRINCIPAL INVESTIGATOR

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RRT, PhD

Model Details: 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).

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: April 5, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)