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CompletedNCT05203536ICEBERGUpdated May 30, 2025

Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

An observational study in Acute Hypoxemic Respiratory Failure, sponsored by University of Milano Bicocca. Completed at 8 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by University of Milano Bicocca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
298
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Hypoxemic Respiratory Failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 298 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

AHRF/ARDS patients on Assisted Mechanical Ventilation modes from international centers will be enrolled. All the pressure-targeted modes of assisted ventilation will be acceptable for the study inclusion.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
298 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Correlation between respiratory system mechanical properties and ICU mortality

    Difference between mean values of driving pressure in survivors and non-survivors at ICU discharge.

    Time frame: 90 days

Secondary outcomes

  1. Correlation between respiratory system compliance and ICU mortality

    Difference between mean values of respiratory system compliance in survivors and non-survivors at ICU discharge.

    Time frame: 90 days

  2. Correlation between plateau pressure and ICU mortality

    Difference between mean values of plateau pressure in survivors and non-survivors at ICU discharge.

    Time frame: 90 days

  3. Correlation between pressure muscle index and ICU mortality

    Difference between mean values of pressure muscle index (PMI) in survivors and non-survivors at ICU discharge.

    Time frame: 90 days

  4. Correlation between muscle pressure and ICU mortality

    Difference between mean values of muscle pressure (Pmus) in survivors and non-survivors at ICU discharge.

    Time frame: 90 days

07

Study locations

8 sites
  • Toronto General Hospital
    Toronto, M5G 2C4, Canada
  • University Medical Centre Schleswig-Holstein
    Kiel, 24105, Germany
  • University Hospital Galway
    Galway, YR71, Ireland
  • Ospedale Sant'Anna
    Ferrara, 44124, Italy
  • Policlinico di Milano Ospedale Maggiore
    Milano, 20122, Italy
  • ASST-Monza, Ospedale San Gerardo
    Monza, 20900, Italy
  • Vall d'Hebron University Hospital
    Barcelona, 08035, Spain
  • Hospital Clinic de Barcelona
    Barcelona, 08036, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05203536
Lead sponsor
University of Milano Bicocca
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Sep 1, 2021
Primary completion
Jun 3, 2023
Completion
Jun 3, 2023
Last update
May 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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