Clinical trial NCT02523352: Effects of PEEP on Heart and Lungs in Obese Subjects
Official title: Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Pulmonary Atelectasis
Obesity Hypoventilation Syndrome
Magnetic Resonance Imaging
Respiratory Mechanics
Electrical Impedance Tomography
Trans-Thoracic Echocardiography
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.

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:

* 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.

Eligibility criteria: 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

Primary outcomes:
measure: End Expiratory Lung Volume
timeFrame: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Secondary outcomes:
measure: Work of breathing
timeFrame: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
measure: Right heart volumes
timeFrame: Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
measure: Heart ejection fraction
timeFrame: Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachussets General Hospital
name: Robert Kacmarek, RRT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Lorenzo Berra, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: 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.
citation: 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.
citation: 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.