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Tests breathing pressure and body position in adults with severe lung failure

Tests how body fat and body position affect breathing in adults on ventilators.

Key facts

Who runs it
Maurizio F. Cereda, MD
Where
Boston, United StatesSee the site
Trial code
Registry title
Adiposity Distribution in Acute Respiratory Failure
Status
Not yet recruiting
People taking part
80 people, planned
Starts
1 Jan 2028
Expected to end
30 Jun 2030
Type of study
Interventional
Treatments tested
  • PEEP Titration Using Electrical Impedance Tomography (EIT)
  • Body Positioning: Supine and Prone
Record updated
13 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults on a breathing machine for sudden low blood oxygen caused by lung injury, across a range of body weights.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Acute hypoxemic respiratory failure with PaO2/FiO2 <= 300 mmHg, on a breathing tube for less than 72 hours.
Earlier treatment
Must have been intubated for less than 72 hours. Must not be in another interventional research study.
Biomarker or test result
An arterial line is needed for blood gas measurement and blood pressure monitoring.

Main reasons for not taking part

  • Pregnant, suspected pregnancy, or less than six weeks after giving birth
  • Pacemaker or internal cardiac defibrillator
  • Pneumothorax, chronic lung disease or pulmonary hypertension
  • Unstable blood pressure or heart
  • Cannot be placed in the prone position, or needs extracorporeal life support

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • AHRF with PaO2/FiO2 <= 300 mmHg) intubated for less than 72 hours
  • Presence of an arterial line for blood gas measurement and blood pressure monitoring
  • 18 years or older

Who cannot take part

  • Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator
  • Preexisting chronic lung disease or pulmonary hypertension
  • Acute cardiac failure causing pulmonary edema
  • Past medical history of lung malignancy or pneumonectomy, or lung transplant
  • Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury
  • Younger than 18 years or older than 80 years
  • Suspected pregnancy, pregnancy or less than six weeks postpartum
  • Subject enrolled in another interventional research study
  • Presence of pneumothorax
  • Hemodynamic instability, defined as:; Persistent systolic blood pressure <90 mmHg and/or >180 mmHg despite the use of vasopressor or vasodilators, or; Requiring an increment in inotropic-vasopressors over the past two hours just before enrollment: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine
  • Extracorporeal life support

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Maurizio F Cereda, MDNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Single Arm: Ventilatory Assessment at Two PEEP Levels and Body PositionsTreatment being tested

    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.

    Treatment: PEEP Titration Using Electrical Impedance Tomography (EIT) and Body Positioning: Supine and Prone

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure
Plain-language title
Tests breathing pressure and body position in adults with severe lung failureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07019987, who can take part
Record updated
13 June 2025