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Adiposity Distribution in Acute Respiratory Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Arterial blood samples (2 mL each) will be obtained at each PEEP level in both positions (four total, 8 mL cumulative) for gas exchange analysis."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Suspected pregnancy, pregnancy or less than six weeks postpartum * Younger than 18 years or older than 80 years. * Subject enrolled in another interventional research study * Presence of pneumothorax * 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 * 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. * Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury * Extracorporeal life support

Study sites (1)

MA