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NCT Number: NCT07265882

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Marco Pozzi, MD

CONTACT

[email protected]

+39 0382503711

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing passive mechanical ventilation

Exclusion criteria

  • hemodynamic instability
  • confirmed intracranial hypertension

Treatment and study plan

Primary outcomes

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

    Time frame: up to 45 months

    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)

Secondary outcomes

  1. Description of classical respiratory mechanics related to lung instability

    Time frame: up to 45 months

    Correlate respiratory system compliance (measured as tidal volume divided by driving pressure) with the degree of lung instability (ie indexed hysteresis)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Pozzi, MD

CONTACT

[email protected]

+39 0382503711

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: BAM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

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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