Acute Hypoxemic Respiratory FailureICEBERGNCT05203536
Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
An observational study of Acute Hypoxemic Respiratory Failure, run by University of Milano Bicocca at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- How many people
- 298 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Sep 2021to 3 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Italy3 sites
Ospedale Sant'Anna
Ferrara, Ferrara, 44124
Policlinico di Milano Ospedale Maggiore
Milan, Milano, 20122
ASST-Monza, Ospedale San Gerardo
Monza, Monza, 20900
Spain2 sites
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: 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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between respiratory system mechanical properties and ICU mortality
Difference between mean values of driving pressure in survivors and non-survivors at ICU discharge.
Measured: 90 days
Secondary outcomes (4)
Correlation between respiratory system compliance and ICU mortality
Difference between mean values of respiratory system compliance in survivors and non-survivors at ICU discharge.
Measured: 90 days
Correlation between plateau pressure and ICU mortality
Difference between mean values of plateau pressure in survivors and non-survivors at ICU discharge.
Measured: 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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Sep 2021
- Primary completion3 Jun 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203536
- Sponsor's protocol ID
- 3552
- Acronym
- ICEBERG
- Status last verified
- May 2025
- First submitted
- 23 Dec 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bastian TM, Eimer C, Behmuller F, Weiler N, Bellani G, Schadler D, Becher T. The P0.1 maneuver as an alternative method for assessing the validity of esophageal pressure measurements during assisted ventilation: an exploratory analysis. Intensive Care Med Exp. 2026 Mar 1;14(1):23. doi: 10.1186/s40635-026-00873-w.
PubMed 41764703
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05203536
- Acronym / sponsor ID
- ICEBERG / 3552
- Conditions
- Acute Hypoxemic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Age <18 years old
- Pregnancy
- Active air leaks
- Moribund state
- High ICP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Correlation between respiratory system compliance and ICU mortality
Time frame: 90 days
Correlation between plateau pressure and ICU mortality
Time frame: 90 days
Correlation between pressure muscle index and ICU mortality
Time frame: 90 days
Correlation between muscle pressure and ICU mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41764703Bastian TM, Eimer C, Behmuller F, Weiler N, Bellani G, Schadler D, Becher T. The P0.1 maneuver as an alternative method for assessing the validity of esophageal pressure measurements during assisted ventilation: an exploratory analysis. Intensive Care Med Exp. 2026 Mar 1;14(1):23. doi: 10.1186/s40635-026-00873-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxemic Respiratory Failure, run by University of Milano Bicocca at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Spain, Canada, Germany, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between respiratory system mechanical properties and ICU mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.