Actively Recruiting
Use of Mechanical Power to Predict Increased Proinflammatory Cytokines in Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
Led by University of Roma La Sapienza · Updated on 2024-05-22
150
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with acute hypoxemic respiratory failure (AHRF) who require mechanical ventilation to understand how many exceed a mechanical power (MP) of 17 joules per minute during the first 72 hours. The study aims to compare the levels of proinflammatory cytokines in blood and lung fluid samples between patients with higher and lower mechanical power. This observational study is sponsored by the University of Roma La Sapienza. Participants are divided into two groups based on their respiratory mechanics: those with average MP below 17 J/min and those with average MP at or above 17 J/min. The study involves collecting blood and bronchoalveolar lavage (BAL) samples for cytokine testing to explore the inflammatory response related to mechanical power during ventilation. During the study, patients will be monitored closely for their mechanical ventilation parameters and undergo sample collection for cytokine analysis. The main outcome measured is the proportion of patients exceeding 17 J/min of mechanical power over four years. Researchers will also assess inflammatory cytokine levels to understand differences between the groups. The study involves ongoing observation and data collection over a planned period ending in 2027.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute hypoxemic respiratory failure (P/F ratio less than 300 mmHg) on invasive mechanical ventilation within 7 days from symptom onset
- Mechanical ventilation started less than 6 hours prior
- New lung consolidation visible on chest imaging (X-ray or CT)
- Age 18 years or older
You will not qualify if you...
- Previous invasive mechanical ventilation during the same hospital stay
- Presence of a tracheostomy
- Severe anemia with hemoglobin less than 7 g/dL
- Severe neutropenia
- Renal insufficiency or on renal replacement therapy
- Use of noradrenaline greater than 0.5 mcg/kg/min
- Pregnancy
- Use of extracorporeal circulation such as ECCO2R or ECMO
- Life expectancy less than 24 hours as determined clinically
- Lack of consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants who undergo mechanical ventilation are observed to assess mechanical power and inflammatory cytokine levels.
Visits scheduled based on clinical care during mechanical ventilation
Trial Site Locations
Total: 1 location
1
Sapienza University of Rome
Roma, Italy, 00161
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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