ARDSNCT04067154
Gas Exchange and CT Effects of PEEP in ARDS
A study testing ALPE in people with ARDS, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- ALPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2012to 1 Aug 2014
- 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
- ARDS patients requiring mechanical ventilation
Who cannot join
- <18 years old
- Requirement of extracorporal life support
- Hemodynamic instability
- Barotrauma
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
About this study
Official title: Does a Bedside Method for Describing Functional Gas Exchange Compare Well With Anatomical Description Via CT Scans, and Could it Predict the Effects of Recruitment and Ventilation/Perfusion Mismatch Improvement
The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results
Read the detailed description
In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP
- Conditions
- ARDS
- Being tested
- ALPE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPEDiagnostic test
Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| ALPE-TAC | Experimental | ARDS patients on mechanical ventilation. Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O to evaluate potential for recruitment and measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O Receives: Diagnostic Test: ALPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas Exchange and lung recruitability at diferent PEEP levels
Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O)
Measured: Approximately two hours
Secondary outcomes (2)
Physiologic Parameter 1
Hemodynamic assessment at different PEEP levels
Measured: Approximately two hours
Physiologic Parameter 2
Respiratory mechanics at different PEEP levels
Measured: Approximately two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Aug 2012
- Primary completion1 Aug 2014
- Study completion1 Aug 2014
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 ARDSStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Panigada, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067154
- Sponsor's protocol ID
- 2425
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karbing DS, Panigada M, Bottino N, Spinelli E, Protti A, Rees SE, Gattinoni L. Changes in shunt, ventilation/perfusion mismatch, and lung aeration with PEEP in patients with ARDS: a prospective single-arm interventional study. Crit Care. 2020 Mar 23;24(1):111. doi: 10.1186/s13054-020-2834-6.
PubMed 32293506
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Bedside Method for Describing Functional Gas Exchange Compare Well With Anatomical Description Via CT Scans, and Could it Predict the Effects of Recruitment and Ventilation/Perfusion Mismatch Improvement
- ClinicalTrials.gov ID
- NCT04067154
- Acronym / sponsor ID
- 2425
- Conditions
- ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Aug 2014 (actual)
- First posted
- 26 Aug 2019 (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 study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results
Detailed description
In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALPE-TAC | Experimental | Diagnostic Test: ALPEARDS patients on mechanical ventilation. Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O to evaluate potential for recruitment and measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ARDS patients requiring mechanical ventilation
Key exclusion criteria (4 listed)
- <18 years old
- Requirement of extracorporal life support
- Hemodynamic instability
- Barotrauma
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 |
|---|---|---|
| ALPEMeasurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O | Diagnostic test | ALPE-TAC |
Primary outcome
Gas Exchange and lung recruitability at diferent PEEP levels
Time frame: Approximately two hours
Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O)
2 secondary outcomes
Physiologic Parameter 1
Time frame: Approximately two hours
Physiologic Parameter 2
Time frame: Approximately two hours
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 26 Aug 2019.
- Derived from this study: PubMed 32293506Karbing DS, Panigada M, Bottino N, Spinelli E, Protti A, Rees SE, Gattinoni L. Changes in shunt, ventilation/perfusion mismatch, and lung aeration with PEEP in patients with ARDS: a prospective single-arm interventional study. Crit Care. 2020 Mar 23;24(1):111. doi: 10.1186/s13054-020-2834-6.
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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 ALPE in people with ARDS, run by Policlinico Hospital 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 1 inclusion and 4 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 26 Aug 2019. 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?
Gas Exchange and lung recruitability at diferent PEEP levels (time frame: Approximately two hours). 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 NCT04067154, 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 26 Aug 2019.