๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-05

Adiposity Distribution in Acute Respiratory Failure (NCT07019987)

Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Maurizio F. Cereda, MD

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution. Two common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions. This study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments.. Patients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.

Who can join: Review the eligibility criteria below.

Location: Massachusetts General Hospital โ€” Boston, Massachusetts

Age range: 18 Years to 80 Years

๐Ÿงช Interventions in This Study

  • PEEP Titration Using Electrical Impedance Tomography (EIT) (OTHER)
  • Body Positioning: Supine and Prone (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Massachusetts General Hospital โ€” Boston, Massachusetts

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 643-0987

Email: mcereda@mgh.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—