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.

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Key information

Conditions

Mechanical Power

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza University of Rome

Roma, 00161, Italy

Location status: Recruiting

Location contact

Francesco Alessandri

CONTACT

[email protected]

0039 0649978924

Giovanni Giordano

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Device

Mechanical ventilatiom

Primary outcomes

Patients who exceed 17 J/min of MP

Time frame: 4 years

Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP

Secondary outcomes

Inflammatory cytokines

Time frame: 4 years

Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: May 22, 2024
Registry last updated: May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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