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

Recruiting

• Conditions: Mechanical Power

• Registration Number: NCT06425354
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2027-04-15
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients who exceed 17 J/min of MP	4 years	Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP

Secondary Outcome Measures

Name	Time	Method
Inflammatory cytokines	4 years	Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Roma, Italy