Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

Acute Hypoxemic Respiratory Failure Clinical Trial

— ICEBERG  

Official title:

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203536
• Other study ID #: 3552
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of Milano Bicocca
• Contact: Giacomo Bellani
• Phone: +390392333293
• Email: giacomo.bellani1[@]unimib.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto
Germany	University Medical Centre Schleswig-Holstein	Kiel
Ireland	University Hospital Galway	Galway
Italy	Ospedale Sant'Anna	Ferrara
Italy	Policlinico di Milano Ospedale Maggiore	Milano
Italy	ASST-Monza, Ospedale San Gerardo	Monza
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Vall d'Hebron University Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Countries where clinical trial is conducted

Canada,  Germany,  Ireland,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation between plateau pressure and ICU mortality	Difference between mean values of plateau pressure in survivors and non-survivors at ICU discharge.	90 days
Secondary	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
Secondary	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