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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | April 15, 2023 |
| Main results expected | April 15, 2027 |
| Study ends | June 15, 2027 |
| Registry record updated | May 22, 2024 |
| Trial ID | NCT06425354 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
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Sapienza University of Rome
Roma, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.