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Completed

NCT Number: NCT05203536

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Correlation between respiratory system compliance and ICU mortality

    Time frame: 90 days

    Difference between mean values of respiratory system compliance in survivors and non-survivors at ICU discharge.

  2. Correlation between plateau pressure and ICU mortality

    Time frame: 90 days

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

  3. Correlation between pressure muscle index and ICU mortality

    Time frame: 90 days

    Difference between mean values of pressure muscle index (PMI) in survivors and non-survivors at ICU discharge.

  4. Correlation between muscle pressure and ICU mortality

    Time frame: 90 days

    Difference between mean values of muscle pressure (Pmus) in survivors and non-survivors at ICU discharge.

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

Acronym: ICEBERG

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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