Bed Side Assessment in Patients With Acute Respiratory Failure Under Invasive Mechanical Ventilation

NCT07265882 | Recruiting

• 1 other identifier: BAM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about the respiratory mechanics in patients undergoing mechanical ventilation. The investigators can achieve this through the offline analysis of data provided by the ventilator. Within the field of respiratory mechanics, the study focuses particularly on the quantification of lung instability. What does lung instability mean? By this definition, the investigators refer to the part of lung tissue that opens during inspiration and then collapses during the subsequent expiration. The more diseased the lung (for example, in the case of viral pneumonia), the greater the quantity of this tissue. How is lung instability measured? In the context of the study analysis, lung instability is measured through the analysis of the low flow pressure-volume loop during ventilation. This graph illustrates how the volume of air in the lungs varies in response to the pressures applied by the ventilator during slow inflation and deflation phases. This maneuver is considered quick and safe and has been an integral part of our clinical practice for several years. Through this maneuver, investigators can examine the range of pressures provided by the ventilator during tidal ventilation. To assess lung instability, hysteresis is analyzed, which represents a distinctive characteristic of the pressure-volume loop. Greater hysteresis indicates a higher degree of lung instability. During the study, investigators will record not only hysteresis but also classical respiratory mechanics parameters (for example, elastance of the respiratory system, i.e., how stiff the lung is), parameters regarding gas exchange (blood oxygen and carbon dioxide levels), biometric data (for example, height and weight), and imaging (CT scans, lung ultrasound, and electrical impedance tomography) to relate them to the degree of lung instability.

Conditions

Acute Respiratory Failure (ARF)

Keywords

respiratory mechanics; ARDS; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Statistical prevalence of respiratory system instability , defined as indexed lung hysteresis at PEEP lower than 10 cmH2O.

  Lung instability is defined as indexed hysteresis \> 100. Where: * Hysteresis (ml) is calculated as the area enclosed between inspiratory and expiratory limb of the low flow pressure volume loop. * indexed hysteresis corresponds to the hysteresis area normalized for the applied driving pressure (plateau pressure minus PEEP)

  up to 45 months

Secondary Outcomes (1)

• Description of classical respiratory mechanics related to lung instability

  up to 45 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to the reference intensive care unit requiring passive mechanical ventilation

You may qualify if:

• patients undergoing passive mechanical ventilation

You may not qualify if:

• hemodynamic instability
• confirmed intracranial hypertension

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

Central Study Contacts

Marco Pozzi, MD

CONTACT

+39 0382503711; ma.pozzi@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: December 5, 2025
• Study Start: November 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)