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Effects of PEEP on Heart and Lungs in Obese Subjects

NCT ID: NCT02523352

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Non-Invasive Ventilation

Intervention Type PROCEDURE

Progressive increase in airway pressure to open lungs atelectatic regions.

Esophageal catheter positioning

Intervention Type PROCEDURE

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

Interventions

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Non-Invasive Ventilation

Progressive increase in airway pressure to open lungs atelectatic regions.

Intervention Type PROCEDURE

Esophageal catheter positioning

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert M. Kacmarek

RRT, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Kacmarek, RRT, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachussets General Hospital

Lorenzo Berra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19910329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21868467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24736287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23640585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24467647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19809292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34099131 (View on PubMed)

Other Identifiers

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EIT-TTE-MRI-Obese

Identifier Type: -

Identifier Source: org_study_id