Clinical trial Recruiting at 1 site Observational Ages 18 and up

Investigating mechanical power's role in respiratory failure and inflammation

Official title: Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

Run by University of Roma La Sapienza · NCT06425354 · Data updated 2026-11-12

This study is trying to see if patients with severe breathing problems who use a certain level of mechanical ventilation power have more inflammation in their lungs compared to those who use less power.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedApril 15, 2023
Main results expectedApril 15, 2027
Study endsJune 15, 2027
Registry record updatedMay 22, 2024
Trial IDNCT06425354 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with acute hypoxemic respiratory failure requiring invasive mechanical ventilation.

Probably not a fit

Patients with prior invasive mechanical ventilation, severe anemia, or those with a life expectancy of less than 24 hours may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the proportion of patients with acute hypoxemic respiratory failure (AHRF) who exceed a mechanical power threshold of 17 J/min during mechanical ventilation. It will compare proinflammatory cytokine concentrations in blood and bronchoalveolar lavage samples between patients with low and high mechanical power. The study will involve measuring respiratory mechanics and collecting biological samples to understand the relationship between mechanical power and inflammation in the lungs.

Why it matters

Potential benefit: If successful, this study could help identify patients at higher risk of inflammation due to mechanical ventilation, potentially guiding more tailored treatment approaches.

How similar studies have gone: While the specific approach of using mechanical power as a predictor of cytokine levels is novel, similar studies have explored mechanical ventilation's impact on inflammation, suggesting potential relevance.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
* Invasive mechanical ventilation for less than 6 hours
* Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
* Age ≥18 years

Exclusion Criteria:

* Prior invasive mechanical ventilation during the same hospitalization
* Tracheostomy
* Severe anemia (Hb\<7g/dL)
* Severe neutropenia
* Renal insufficiency or RRT (Renal Replacement Therapy)
* Noradrenaline \>0.5 mcg/kg/min
* Pregnancy
* Extracorporeal circulation (ECCO2R, ECMO)
* Life expectancy \<24 hours as clinically judged
* Lack of consent

Where it's running

  • Sapienza University of Rome
    Roma, Italy
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.