Mechanical Ventilation ComplicationNCT04429399
Lowering PEEP: Weaning From High PEEP Setting
A study testing decrease the positive end expiratory pressure (PEEP), mechanical features assessment and shunt assessment in people with Mechanical Ventilation Complication, run by University of Bari at 1 site in Italy.
Trial summary
The perfusion of the deeply different areas coexisting in ARDS lung generates two type of venus-admixure : true shunt and shunt effect. Briefly, true shunt and shunt effect are related to non-aerated and poorly-ventilated lung areas perfusion respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- decrease the positive end expiratory pressure (PEEP), mechanical features assessment and shunt assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 21 Sep 2019to 1 Jan 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age major than 18
- 1-2 days since the beginning of mechanical ventilation
- Moderate or severe ARDS
Who cannot join
- Patients with a story of chronic obstructive pulmonary disease (COPD)
- Patients with asthma
- Patients with neurological disease
- Patients with heart disease
- Patients with cardiopulmonary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Positive End Expiratory Pressure (PEEP) Decrease in Patient With Acute Respiratory Distress Syndrome (ARDS) Ventilated According to High PEEP Strategy (ExPress Trial).
The perfusion of the deeply different areas coexisting in ARDS lung generates two type of venus-admixure : true shunt and shunt effect. Briefly, true shunt and shunt effect are related to non-aerated and poorly-ventilated lung areas perfusion respectively. Practically, it is not possible to quantify the true shunt and the shunt-effect directly, but we can measure the "total-shunt", i.e. the sum of two kind of venus-admixured. As it is known from classical physiology, the effects of FiO2 variations on PaO2 are deeply different depending on the type of venous admixures. In the case of a patient with virtually only true shunt, any FiO2 variation will not modify the PaO2. On the other hand, in a patient with virtually only a shunt effect, increasing the FiO2 the PaO2 will progressively increase. Indeed, ventilating a patient presenting only a shunt effect (without true shunt) with pure oxygen will generate a "normal" P/F ratio. In patients ventilated with high PEEP levels it is difficult to predict based on the P/F ratio the relative amount of true shunt and shunt effect. However, patients presenting a significant shunt effect when ventilated with higher PEEP level would likely have "unstable" poorly aerated lung areas that need PEEP to remain opened. In those patients, a PEEP-weaning protocol based on the P/F ratio could induce significant alveolar de-recruitment and clinical deterioration. On the contrary, patients with less shunt effect would be likely less prone to alveolar de-recruitment and would benefice from PEEP decrease.
Read the detailed description
the investigators set up a study to test the hypothesis that patients presenting a significant shunt effect when ventilated with higher PEEP levels could be prone to significant alveolar de-recruitment at the PEEP weaning attempt. To do so, the investigator has to measure the total shunt at higher PEEP level in patients ready to be weaned from the PEEP (according to the Mercat protocol), at three FiO2 levels (i.e. 0,3, 0,6 and 1). The shunt effect is quantified as the difference in total shunt between FiO2 0,3 and .The hypothesis of this study is that the shunt effect could predict alveolar de-recruitment when weaning PEEP.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- decrease the positive end expiratory pressure (PEEP), mechanical features assessment, shunt assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decrease the positive end expiratory pressure (PEEP)Other
decrease the PEEP going from high (according to ExPress Trial) to low level
mechanical features assessmentOther
evaluation of the mechanical features of respiratory system
shunt assessmentOther
evaluation of the pulmonary shunt during two different ventilation setting
| Study group | Role | What they receive |
|---|---|---|
| High positive end-expiratory pressure Ventilation | Other | patient ventilated fixing high level of positive end expiratory pressure Receives: Other: decrease the positive end expiratory pressure (PEEP); Other: mechanical features assessment; Other: shunt assessment |
| Low positive end-expiratory pressure Ventilation | Other | patient ventilated fixing low level of positive end expiratory pressure Receives: Other: mechanical features assessment; Other: shunt assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
de-recruitment
the shunt effect cold predict the lung de-recruitment volume
Measured: decreasing PEEP from high to low levelthrough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start21 Sep 2019
- Primary completion21 Jun 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Grasso, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429399
- Sponsor's protocol ID
- 6011
- Status last verified
- Jan 2022
- First submitted
- 4 Jun 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End Expiratory Pressure (PEEP) Decrease in Patient With Acute Respiratory Distress Syndrome (ARDS) Ventilated According to High PEEP Strategy (ExPress Trial).
- ClinicalTrials.gov ID
- NCT04429399
- Acronym / sponsor ID
- 6011
- Conditions
- Mechanical Ventilation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Jun 2020 (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 perfusion of the deeply different areas coexisting in ARDS lung generates two type of venus-admixure : true shunt and shunt effect. Briefly, true shunt and shunt effect are related to non-aerated and poorly-ventilated lung areas perfusion respectively. Practically, it is not possible to quantify the true shunt and the shunt-effect directly, but we can measure the "total-shunt", i.e. the sum of two kind of venus-admixured. As it is known from classical physiology, the effects of FiO2 variations on PaO2 are deeply different depending on the type of venous admixures. In the case of a patient with virtually only true shunt, any FiO2 variation will not modify the PaO2. On the other hand, in a patient with virtually only a shunt effect, increasing the FiO2 the PaO2 will progressively increase. Indeed, ventilating a patient presenting only a shunt effect (without true shunt) with pure oxygen will generate a "normal" P/F ratio. In patients ventilated with high PEEP levels it is difficult to predict based on the P/F ratio the relative amount of true shunt and shunt effect. However, patients presenting a significant shunt effect when ventilated with higher PEEP level would likely have "unstable" poorly aerated lung areas that need PEEP to remain opened. In those patients, a PEEP-weaning protocol based on the P/F ratio could induce significant alveolar de-recruitment and clinical deterioration. On the contrary, patients with less shunt effect would be likely less prone to alveolar de-recruitment and would benefice from PEEP decrease.
Detailed description
the investigators set up a study to test the hypothesis that patients presenting a significant shunt effect when ventilated with higher PEEP levels could be prone to significant alveolar de-recruitment at the PEEP weaning attempt. To do so, the investigator has to measure the total shunt at higher PEEP level in patients ready to be weaned from the PEEP (according to the Mercat protocol), at three FiO2 levels (i.e. 0,3, 0,6 and 1). The shunt effect is quantified as the difference in total shunt between FiO2 0,3 and .The hypothesis of this study is that the shunt effect could predict alveolar de-recruitment when weaning PEEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High positive end-expiratory pressure Ventilation | Other | Other: decrease the positive end expiratory pressure (PEEP), Other: mechanical features assessment, Other: shunt assessmentpatient ventilated fixing high level of positive end expiratory pressure |
| Low positive end-expiratory pressure Ventilation | Other | Other: mechanical features assessment, Other: shunt assessmentpatient ventilated fixing low level of positive end expiratory pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age major than 18
- 1-2 days since the beginning of mechanical ventilation
- Moderate or severe ARDS
Key exclusion criteria (5 listed)
- Patients with a story of chronic obstructive pulmonary disease (COPD)
- Patients with asthma
- Patients with neurological disease
- Patients with heart disease
- Patients with cardiopulmonary.
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 |
|---|---|---|
| decrease the positive end expiratory pressure (PEEP)decrease the PEEP going from high (according to ExPress Trial) to low level | Other | High positive end-expiratory pressure Ventilation |
| mechanical features assessmentevaluation of the mechanical features of respiratory system | Other | High positive end-expiratory pressure Ventilation, Low positive end-expiratory pressure Ventilation |
| shunt assessmentevaluation of the pulmonary shunt during two different ventilation setting | Other | High positive end-expiratory pressure Ventilation, Low positive end-expiratory pressure Ventilation |
Primary outcome
de-recruitment
Time frame: decreasing PEEP from high to low levelthrough study completion, an average of 2 years
the shunt effect cold predict the lung de-recruitment volume
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 21 Jan 2022.
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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?
A study testing decrease the positive end expiratory pressure (PEEP), mechanical features assessment and shunt assessment in people with Mechanical Ventilation Complication, run by University of Bari 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 3 inclusion and 5 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 21 Jan 2022. 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?
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?
de-recruitment (time frame: decreasing PEEP from high to low levelthrough study completion, an average of 2 years). 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 21 Jan 2022.