Adiposity Distribution in Acute Respiratory Failure

Conditions

• Acute Hypoxemic Respiratory Failure
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 1, 2028

Status verified

Jun 2025

Primary completion

Dec 31, 2029

Completion

Jun 30, 2030

Study Design

Enrollment

80 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions
  A total of 80 patients will undergo sequential assessments during mechanical ventilation at two levels of PEEP: 1. Clinician-set PEEP (PEEP\_CLIN) 2. PEEP determined by EIT-guided titration (PEEP\_TIT) These interventions will be applied first in the supine position, with each PEEP level maintained for approximately 30 minutes. Afterward, patients will be repositioned to the prone position, and the same assessments and EIT-guided PEEP titration will be repeated.

Primary Outcome Measure

Driving pressure with PEEP titration and prone position [ Time Frame: Day 1, after 30 minutes in each combination of PEEP and body position ]

Central Contacts

• Maurizio F Cereda, MD
  16176430987
  [email protected]
• Lorenzo Berra, MD
  617 724 0743
  [email protected]

Locations (1)

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