Respiratory Mechanics Assessment During Assisted Mechanical Ventilation (ICEBERG)

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Acute Hypoxemic Respiratory Failure

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between respiratory system compliance and ICU mortality	Difference between mean values of respiratory system compliance in survivors and non-survivors at ICU discharge.	90 days
Correlation between plateau pressure and ICU mortality	Difference between mean values of plateau pressure in survivors and non-survivors at ICU discharge.	90 days
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.	90 days
Correlation between muscle pressure and ICU mortality	Difference between mean values of muscle pressure (Pmus) in survivors and non-survivors at ICU discharge.	90 days

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 3, 2023
• Study Completion (Actual): June 3, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 3552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No