Acute Lung InjuryPAVELANCT06290310
Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography
An observational study of Acute Lung Injury, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
Trial summary
Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- EIT and patient-ventilator asynchrony assessment
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteHungary
- Study dates
- 12 Apr 2024to 1 Sep 2024
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: mechanically ventilated patients
Who may be able to join
- any patient ventilated invasively
- any patient ventilated non-invasively
Who cannot join
- age under 18
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged
Kiskunhalas, 6400
András Lovas, M.D. Ph.D., 003677522000 ext. 2045, landras@halasi-korhaz.hu
About this study
Official title: Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography and Artificial Intelligence
Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony.
Read the detailed description
Patient-ventilator asynchrony (PVA) is a common phenomenon with invasively- and non-invasively ventilated patients. PVA has deleterious effects on the lungs. It causes not just patient discomfort and distress but also leads to acute lung injury and worsening hypoxemia through biotrauma. The latter significantly impacts outcomes and increases the duration of mechanical ventilation and intensive care unit stay.
However, PVA is a widely investigated incident related to mechanical ventilation, though little is known about how it affects lung aeration estimated by electric impedance tomography (EIT). EIT is a non-invasive, real-time monitoring technique suitable for detecting changes in lung volumes during ventilation.
Artificial intelligence can promote the detection of PVA by flow versus time assessment. If continuous EIT recording is correlated with the latter, impedance tomography changes evoked by asynchrony can be estimated
- Conditions
- Acute Lung Injury
- Being tested
- EIT, patient-ventilator asynchrony assessment
- Keywords
- artificial intelligence, biotrauma, electric impedance tomography, patient-ventilator asynchrony
- Medical subject headings
- Acute Lung Injury, Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EITDevice
continuous electric impedance tomography measurement
patient-ventilator asynchrony assessmentDevice
patient-ventilator asynchrony assessment by flow/time curve and machine learning
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated patients | Invasively or non-invasively ventilated patients. Receives: Device: EIT; Device: patient-ventilator asynchrony assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
distribution
gas distribution in lungs assessed by electric impedance tomography
Measured: during mechanical ventilation
Secondary outcomes (2)
connecting asysnchrony cycles with electric impedance tomography measurements
connecting machine learning assessed patient-ventilator asynchrony respiratory cycles with the inherent respiratory cycle recorded by the electric impedance tomography
Measured: during mechanical ventilation
identifying unic electric impedance tomography signs of asynchrony
following connection described under "outcome 2", identification if single patient-ventilator asynchrony types (delayed cycling, premature cycling, auto trigger, ineffective effort, double trigger) present specific electric impedance tomography changes
Measured: during mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start12 Apr 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
- Sponsor type
- Other government
- Collaborators
- Hochschule Furtwangen University, Budapest University of Technology and Economics, Szeged University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290310
- Sponsor's protocol ID
- PAVELA
- Acronym
- PAVELA
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.
PubMed 33381233Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.
PubMed 30360753
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06290310
- Acronym / sponsor ID
- PAVELA / PAVELA
- Conditions
- Acute Lung Injury
- Keywords
- artificial intelligence, biotrauma, electric impedance tomography, patient-ventilator asynchrony
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of SzegedOther government
- Collaborators
- Hochschule Furtwangen University, Budapest University of Technology and Economics, Szeged University
- Study start
- 12 Apr 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Mar 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.
Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony.
Detailed description
Patient-ventilator asynchrony (PVA) is a common phenomenon with invasively- and non-invasively ventilated patients. PVA has deleterious effects on the lungs. It causes not just patient discomfort and distress but also leads to acute lung injury and worsening hypoxemia through biotrauma. The latter significantly impacts outcomes and increases the duration of mechanical ventilation and intensive care unit stay.
However, PVA is a widely investigated incident related to mechanical ventilation, though little is known about how it affects lung aeration estimated by electric impedance tomography (EIT). EIT is a non-invasive, real-time monitoring technique suitable for detecting changes in lung volumes during ventilation.
Artificial intelligence can promote the detection of PVA by flow versus time assessment. If continuous EIT recording is correlated with the latter, impedance tomography changes evoked by asynchrony can be estimated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated patients | – | Device: EIT, Device: patient-ventilator asynchrony assessmentInvasively or non-invasively ventilated patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- mechanically ventilated patients
Key inclusion criteria (2 listed)
- any patient ventilated invasively
- any patient ventilated non-invasively
Key exclusion criteria (1 listed)
- age under 18
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 |
|---|---|---|
| EITcontinuous electric impedance tomography measurement | Device | mechanically ventilated patients |
| patient-ventilator asynchrony assessmentpatient-ventilator asynchrony assessment by flow/time curve and machine learning | Device | mechanically ventilated patients |
Primary outcome
distribution
Time frame: during mechanical ventilation
gas distribution in lungs assessed by electric impedance tomography
2 secondary outcomes
connecting asysnchrony cycles with electric impedance tomography measurements
Time frame: during mechanical ventilation
identifying unic electric impedance tomography signs of asynchrony
Time frame: during mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Results publication: PubMed 33381233Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.
- Results publication: PubMed 30360753Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.
- Individual participant dataSharing planned: No
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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.
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 Acute Lung Injury, run by Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged at 1 site in Hungary.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact András Lovas, M.D. Ph.D. (003677522000 ext. 2045, landras@halasi-korhaz.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distribution (time frame: during mechanical ventilation). 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 NCT06290310, which also lists 2 linked publications.
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 4 Mar 2024.