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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06425354
Enrollment
150
Registered
2024-05-22
Start date
2023-04-15
Completion date
2027-06-15
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Power

Brief summary

The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage. The main questions it aims to answer are: 1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation? 2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min? Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.

Interventions

DEVICEMechanical ventilation

Mechanical ventilatiom

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patients who exceed 17 J/min of MP4 yearsProportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP

Secondary

MeasureTime frameDescription
Inflammatory cytokines4 yearsDifference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026