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Adiposity Distribution in Acute Respiratory Failure

NCT07019987 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Acute Hypoxemic Respiratory Failure
  • Obesity

Interventions

OTHER

PEEP Titration Using Electrical Impedance Tomography (EIT)

EIT will be used to guide individualized PEEP titration in mechanically ventilated patients with AHRF. Each subject will receive mechanical ventilation at two PEEP levels: PEEP\_CLIN (set by the treating clinician) PEEP\_TIT (identified using EIT to minimize alveolar collapse and overdistension) Both levels will be maintained for 30 minutes in each body position, with continuous physiologic data collected during each phase.

PROCEDURE

Body Positioning: Supine and Prone

Each subject will be ventilated in both the supine and prone positions. Positioning will follow institutional protocols and be coordinated with clinical staff to ensure safety. After supine assessments are completed, the patient will be transitioned to prone, followed by a recruitment maneuver to standardize lung volume history. The PEEP titration protocol will then be repeated in the prone position.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Maurizio F. Cereda, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-01
Primary Completion
2029-12-31
Completion
2030-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019987 on ClinicalTrials.gov