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临床试验/NCT07019831
NCT07019831尚未招募不适用

Imaging the Respiratory Effects of Truncal Adiposity in Healthy Subjects

Maurizio F. Cereda, MD0 个研究点目标入组 20 人开始时间: 2028年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
Lung volumes

研究概览

简要总结

This study investigates how body fat distribution affects airway closure and lung mechanics in healthy adults. Using Electrical Impedance Tomography (EIT), esophageal manometry, and computed tomography (CT), we aim to characterize how varying BMI and fat topography influence regional ventilation and airway collapse in supine and prone positions. Healthy volunteers with a range of BMIs will undergo a 2-hour imaging session with noninvasive and minimally invasive monitoring.

详细描述

This physiological research study explores the relationship between body habitus, fat distribution, and mechanical responses of the lung to the prone and supine position. In a prospective, single-center, physiological, crossover study, study subjects (n=20) will be recruited among healthy volunteers across BMI categories. Lung function will be assessed in the supine and prone position (maintained for 15 min). Intrathoracic pressure (ITP) will be measured using esophageal manometry. Airway opening pressure (AOP) will be measured by as the airway pressure (non-invasively applied through a mask) needed to match ITP. Regional ventilation will be measured in both positions using electrical impedance tomography. Subjects will then transfer to the computed tomography (CT) scanner, where supine and prone images will be acquired during breath holds after normal expiration and after full inspiration. CT scans will then be analyzed for the quantification of lung volumes, thoracic adipose mass and airway geometry.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects older than 18 years and younger than 80.

排除标准

  • •Pre-existing cardiopulmonary disease
  • •history of tobacco or ecigarette smoking

研究组 & 干预措施

Single arm, respiratory mechanics and adipose distribution in two body positions

Experimental

A total of 20 healthy volunteers will undergo assessments of respiratory mechanics in the supine and prone position. Then, the same subjects will undergo CT scans of the lungs in both positions. Body positions will be randomly applied for 15 minutes each.

干预措施: Body positioning (Procedure)

结局指标

主要结局

Lung volumes

时间窗: Day 1, 15 minutes after breathing in the supine and in the prone position

Lung volumes will be measured from quantitative analysis of CT scans obtained in the supine and in the prone position.

次要结局

  • Thoracic adiposity(Day 1)

研究者

发起方
Maurizio F. Cereda, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maurizio F. Cereda, MD

Associate Professor of Anesthesia

Massachusetts General Hospital

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