Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
ICEBERG
ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
1 other identifier
observational
298
5 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2023
CompletedMay 30, 2025
May 1, 2025
1.8 years
December 23, 2021
May 23, 2025
Conditions
Outcome Measures
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.
90 days
Secondary Outcomes (4)
Correlation between respiratory system compliance and ICU mortality
90 days
Correlation between plateau pressure and ICU mortality
90 days
Correlation between pressure muscle index and ICU mortality
90 days
Correlation between muscle pressure and ICU mortality
90 days
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Age \<18 years old
- Pregnancy
- Active air leaks
- Moribund state
- High ICP
- Patient has passed a spontaneous breathing trial (if performed for clinical indication)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Toronto General Hospital
Toronto, Toronto, M5G 2C4, Canada
University Medical Centre Schleswig-Holstein
Kiel, Kiel, 24105, Germany
University Hospital Galway
Galway, Galway, YR71, Ireland
Ospedale Sant'Anna
Ferrara, Ferrara, 44124, Italy
Policlinico di Milano Ospedale Maggiore
Milan, Milano, 20122, Italy
ASST-Monza, Ospedale San Gerardo
Monza, Monza, 20900, Italy
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2021
First Posted
January 24, 2022
Study Start
September 1, 2021
Primary Completion
June 3, 2023
Study Completion
June 3, 2023
Last Updated
May 30, 2025
Record last verified: 2025-05