NCT07019987Not yet recruiting
Adiposity Distribution in Acute Respiratory Failure
Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 20 May 2025
- Start date
- 1 Jan 2028
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Maurizio F. Cereda, MD
- Diseases
- Obesity
- NCT number
- NCT07019987
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jan 2028 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Younger than 18 years or older than 80 years.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.