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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Power
• Intervention / Treatment: Device: Mechanical ventilation

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Recruiting
    • Sapienza University of Rome
    • Contact: Francesco Alessandri; Phone Number: 0039 0649978924; Email: f.alessandri@uniroma1.it
    • Principal Investigator: Giovanni Giordano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AHRF undergoing mechanical ventilation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients who exceed 17 J/min of MP	Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory cytokines	Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.	4 years

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: RIA24.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No