Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05203536

Acronym

ICEBERG

Enrollment

298

Registered

2022-01-24

Start date

2021-09-01

Completion date

2023-06-03

Last updated

2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypoxemic Respiratory Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between respiratory system mechanical properties and ICU mortality	90 days	Difference between mean values of driving pressure in survivors and non-survivors at ICU discharge.

Secondary

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

Countries

Canada, Germany, Ireland, Italy, Spain

Outcome results