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

Mechanical Power Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425354
• Other study ID #: RIA24.1
• Status: Recruiting
• Start date: April 15, 2023
• Est. completion date: June 15, 2027

Study information

• Verified date: May 2024
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 15, 2027
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Power
• Respiratory Insufficiency

Intervention

Device:
• Mechanical ventilation
Mechanical ventilatiom

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inflammatory cytokines	Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.	4 years