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Search / Trial NCT07019987

Adiposity Distribution in Acute Respiratory Failure

Launched by MAURIZIO F. CEREDA, MD · Jun 5, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Acute Hypoxemic Respiratory Failure Obesity Electrical Impedance Tomography Esophageal Manometry Mechanical Ventilation Prone Positioning Positive End Expiratory Pressure

ClinConnect Summary

This clinical trial is studying how body weight and the way fat is distributed in the body affect lung function in patients with Acute Hypoxemic Respiratory Failure (AHRF). AHRF is a serious condition where the lungs struggle to get enough oxygen due to injury. The trial will investigate whether two common treatments—positive end-expiratory pressure (PEEP) and lying face down (prone positioning)—work equally well for patients with different body types. To do this, researchers will use special tools to measure how well the lungs are inflating and to check for any signs of inflammation.

To participate in this study, you need to be 18 years or older and have AHRF that requires mechanical ventilation, among other criteria. Some people may not be eligible, such as those who are pregnant, have certain lung or heart conditions, or are younger than 18. If you join the trial, you will undergo tests that involve different settings of PEEP and body positions for 30 minutes each. After the study, your medical team will continue to provide care based on your specific needs. This research aims to better understand how to help patients with AHRF, especially those with varying body types.

Gender

ALL

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

About Maurizio F. Cereda, Md

Dr. Maurizio F. Cereda, MD, is a distinguished clinical trial sponsor with a robust background in medical research and patient care. With a focus on advancing therapeutic interventions and improving patient outcomes, Dr. Cereda leads innovative clinical trials that address critical health challenges. His expertise spans various medical disciplines, underscoring his commitment to scientific rigor and ethical standards in research. Through collaboration with multidisciplinary teams, Dr. Cereda aims to drive meaningful advancements in healthcare, ensuring that clinical trials are conducted with the utmost integrity and dedication to participant well-being.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported