Skip to main content
Clinical Trials/NCT05203536
NCT05203536
Completed
Not Applicable

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

University of Milano Bicocca8 sites in 5 countries298 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Hypoxemic Respiratory Failure
Sponsor
University of Milano Bicocca
Enrollment
298
Locations
8
Primary Endpoint
Correlation between respiratory system mechanical properties and ICU mortality
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
June 3, 2023
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Correlation between respiratory system mechanical properties and ICU mortality

Time Frame: 90 days

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

Secondary Outcomes

  • Correlation between respiratory system compliance and ICU mortality(90 days)
  • Correlation between pressure muscle index and ICU mortality(90 days)
  • Correlation between plateau pressure and ICU mortality(90 days)
  • Correlation between muscle pressure and ICU mortality(90 days)

Study Sites (8)

Loading locations...

Similar Trials