Clinical trial

Adiposity Distribution in Acute Respiratory Failure

Opening soon · Not applicable · 1 countries · Registry ID NCT07019987

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionAcute Hypoxemic Respiratory Failure, Obesity

Full registry 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

Treatments and study arms

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.

Primary outcomes

Driving pressure with PEEP titration and prone positionDay 1, after 30 minutes in each combination of PEEP and body position

The primary outcome will be the difference in driving pressure (inspiratory plateau pressure minus total PEEP, in cmH2O) in response to PEEP titration strategies and to prone position. Changes in driving pressure will be correlated with body mass index, and with measurements of thoracic, and abdominal circumference.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Massachusetts General Hospital🇺🇸 Boston, Massachusetts, United States

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Maurizio F Cereda, MDContact

Email · Call 6176430987

Lorenzo Berra, MDContact

Email · Call 617 724 0743