Investigating mechanical power's role in respiratory failure and inflammation
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
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06425354 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute hypoxemic respiratory failure requiring invasive mechanical ventilation.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- Sapienza University of Rome — Roma, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.