Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

Completed

• Conditions: Acute Hypoxemic Respiratory Failure

• Registration Number: NCT05203536
• Lead Sponsor: University of Milano Bicocca

Brief Summary

To verify the association between respiratory system mechanical properties (ΔP, ΔPL,dyn, Pmus, Pplat and CRS and CL,dyn) assessed during assisted modes of ventilation (as average over the first three days since enrollment) and ICU mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-01-24
• Primary Completion: 2023-06-03
• Study Completion: 2023-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

• Acute Hypoxaemic Respiratory Failure (defined as respiratory failure requiring invasive mechanical ventilation with a PaO2/FiO2< 300 mmHg) during the course of ICU stay (including ARDS).
• Invasive mechanical ventilation in one of these modes: Pressure A/C, PRVC, SIMV PC, PSV, NAVA, PAV+, BiPAP
• Presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 48 hours
• Patient for full active management at this point.

Exclusion Criteria

• Age <18 years old
• Pregnancy
• Active air leaks
• Moribund state
• High ICP
• Patient has passed a spontaneous breathing trial (if performed for clinical indication)
• Known COPD with history of home oxygen therapy and/or non invasive ventilation and/or GOLD III-IV. Non invasive ventilation for sleep apnea is NOT an exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between respiratory system mechanical properties and ICU mortality	90 days	Difference between mean values of driving pressure in survivors and non-survivors at ICU discharge.

Secondary Outcome Measures

Name	Time	Method
Correlation between respiratory system compliance and ICU mortality	90 days	Difference between mean values of respiratory system compliance in survivors and non-survivors at ICU discharge.
Correlation between pressure muscle index and ICU mortality	90 days	Difference between mean values of pressure muscle index (PMI) in survivors and non-survivors at ICU discharge.
Correlation between plateau pressure and ICU mortality	90 days	Difference between mean values of plateau pressure in survivors and non-survivors at ICU discharge.
Correlation between muscle pressure and ICU mortality	90 days	Difference between mean values of muscle pressure (Pmus) in survivors and non-survivors at ICU discharge.

Trial Locations

Locations (8)

Toronto General Hospital; 🇨🇦 Toronto, Canada

University Medical Centre Schleswig-Holstein; 🇩🇪 Kiel, Germany

Ospedale Sant'Anna; 🇮🇹 Ferrara, Italy

Policlinico di Milano Ospedale Maggiore; 🇮🇹 Milano, Italy

ASST-Monza, Ospedale San Gerardo; 🇮🇹 Monza, Italy

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

University Hospital Galway; 🇮🇪 Galway, Ireland