HypoxemiaavengARDSNCT06513299
Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients
An observational study of Hypoxemia and Ards, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 1 site in Italy.
Trial summary
The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- low tidal volume, high tidal volume and low driving pressure
- Type of treatment
- Medical device
- How many people
- 4,300 participants
- Where
- 1 siteItaly
- Study dates
- 24 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All adult patients admitted to an ICU adopting MargheritaTre as electronic health record satisfying inclusion and exclusion criteria.
Who may be able to join
- all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes:
- arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg
- hypoxemia developed within one week of a known clinical insult
- hypoxemia not fully explained by cardiac failure or fluid overload*
Who cannot join
- pregnancy
- expected duration of mechanical ventilation < 48h
- severe or moderate COPD
- chronic liver disease
- acute brain injury
- patient admitted for palliative sedation
Show all 13Show fewer
- tumor with metastases
- prior cardiac arrest
- New York Heart Association Class IV
- acute coronary syndrome
- patients transferred from other ICUs
- patients transferred to the ICU from the Emergency Department after a duration exceeding 24 hours in the Emergency Department
- patients on Pressure Support Ventilation and/or patients in whom end-inspiratory plateau pressure was not measured
Trial locations and contacts
1 site in 1 country.
Italy1 site
Mario Negri Institute for Pharmacological Research IRCCS
Ranica, BG, 24020
About this study
Official title: Assessing the Effectiveness of Low Tidal Volume and Low Driving Pressure in Mechanically Ventilated Severe Hypoxemic Patients: a Multicenter Emulated Target Trial
The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.
Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.
- Being tested
- low tidal volume, high tidal volume, low driving pressure, high driving pressure
- Medical subject headings
- Hypoxia, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low tidal volumeDevice
Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 6.0 ml/kg PBW and 8.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.
high tidal volumeDevice
Patients ventilated with assist/control modes of mechanical ventilation with tidal volume between 8.0 ml/Kg PBW and 10.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.
low driving pressureDevice
Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 7.0 cmH2O and 12.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.
high driving pressureDevice
Patients ventilated with assist/control modes of mechanical ventilation with driving pressure between 12.0 cmH2O and 18.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| VT1 - low tidal volume | Patients mechanically ventilated with tidal volume between 6.0 and 8.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. Receives: Device: low tidal volume | |
| VT2 - high tidal volume | Patients mechanically ventilated with tidal volume between 8.0 and 10.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. Receives: Device: high tidal volume | |
| ∆P1 - low driving pressure | Patients mechanically ventilated with driving pressure between 7.0 and 12.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. Receives: Device: low driving pressure | |
| ∆P2 - high driving pressure | Patients mechanically ventilated with driving pressure between 12.0 and 18.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. Receives: Device: high driving pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU all-cause mortality
All patients will be classified as either alive if "alive at ICU discharge" or dead if "dead at ICU discharge"
Measured: 14 days from assignment to intervention arm
Secondary outcomes (1)
Ventilator-free days
Number of ventilator-free days (VFDs) during the 14 days in ICU
Measured: 14 days from assignment to intervention arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start24 Dec 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Retrospective
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, University of Bari Aldo Moro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513299
- Sponsor's protocol ID
- avengARDS
- Acronym
- avengARDS
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Low Tidal Volume and Low Driving Pressure in Mechanically Ventilated Severe Hypoxemic Patients: a Multicenter Emulated Target Trial
- ClinicalTrials.gov ID
- NCT06513299
- Acronym / sponsor ID
- avengARDS / avengARDS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,300 participants (estimated)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, University of Bari Aldo Moro
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.
Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VT1 - low tidal volume | – | Device: low tidal volumePatients mechanically ventilated with tidal volume between 6.0 and 8.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
| VT2 - high tidal volume | – | Device: high tidal volumePatients mechanically ventilated with tidal volume between 8.0 and 10.0 ml/kg PBW, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
| ∆P1 - low driving pressure | – | Device: low driving pressurePatients mechanically ventilated with driving pressure between 7.0 and 12.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
| ∆P2 - high driving pressure | – | Device: high driving pressurePatients mechanically ventilated with driving pressure between 12.0 and 18.0 cmH2O, until weaning conditions are satisfied. When weaning criteria are met, extubation may be attempted, it may either fail or not, or any other mechanical ventilation regime may be chosen, according to clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to an ICU adopting MargheritaTre as electronic health record satisfying inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes:
- arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg
- hypoxemia developed within one week of a known clinical insult
- hypoxemia not fully explained by cardiac failure or fluid overload*
Key exclusion criteria (13 listed)
- pregnancy
- expected duration of mechanical ventilation < 48h
- severe or moderate COPD
- chronic liver disease
- acute brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low tidal volumePatients ventilated with assist/control modes of mechanical ventilation with tidal volume between 6.0 ml/kg PBW and 8.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. | Device | VT1 - low tidal volume |
| high tidal volumePatients ventilated with assist/control modes of mechanical ventilation with tidal volume between 8.0 ml/Kg PBW and 10.0 ml/kg PBW with PPLAT ≤ 30 cmH2O, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. | Device | VT2 - high tidal volume |
| low driving pressurePatients ventilated with assist/control modes of mechanical ventilation with driving pressure between 7.0 cmH2O and 12.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. | Device | ∆P1 - low driving pressure |
| high driving pressurePatients ventilated with assist/control modes of mechanical ventilation with driving pressure between 12.0 cmH2O and 18.0 cmH2O with VT ≤ 10 ml/kg PBW, until weaning criteria are met: P/F ratio > 250 mmHg; PEEP ≤ 8 cmH2O and lower than the previous day; FiO2 < 0.5 and lower than the previous day; systolic arterial pressure ≥ 85 mmHg. | Device | ∆P2 - high driving pressure |
Primary outcome
ICU all-cause mortality
Time frame: 14 days from assignment to intervention arm
All patients will be classified as either alive if "alive at ICU discharge" or dead if "dead at ICU discharge"
1 secondary outcome
Ventilator-free days
Time frame: 14 days from assignment to intervention arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia and Ards, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 1 site in Italy.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
ICU all-cause mortality (time frame: 14 days from assignment to intervention arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.