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

NCT06425354 | Recruiting

• 1 other identifier: RIA24.1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 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. 2.Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min?

Conditions

Mechanical Power

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory cytokines

  4 years

Interventions

Mechanical ventilation DEVICE

Mechanical ventilatiom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AHRF undergoing mechanical ventilation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, 00161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma serum and BAL

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: April 15, 2023
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

IT (1)