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Effects of PEEP on Heart and Lungs in Obese Subjects

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02523352
Enrollment
35
Registered
2015-08-14
Start date
2018-04-05
Completion date
2022-12-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURENon-Invasive Ventilation

Progressive increase in airway pressure to open lungs atelectatic regions.

PROCEDUREEsophageal catheter positioning

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
End Expiratory Lung VolumeChange from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)Difference in end expiratory lung volume measured in mL

Secondary

MeasureTime frameDescription
Work of breathingChange 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 volumesChange 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 fractionChanges from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline)Difference in heart ejection fraction will be measured

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026