Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography (PAVELA)

March 1, 2024 updated by: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Kiskunhalas, Hungary, 6400
        • Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

mechanically ventilated patients

Description

Inclusion Criteria:

  • any patient ventilated invasively
  • any patient ventilated non-invasively

Exclusion Criteria:

  • age under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mechanically ventilated patients
Invasively or non-invasively ventilated patients.
Device: EIT
continuous electric impedance tomography measurement
Device: patient-ventilator asynchrony assessment
patient-ventilator asynchrony assessment by flow/time curve and machine learning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distribution
Time Frame: during mechanical ventilation
gas distribution in lungs assessed by electric impedance tomography
during mechanical ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
connecting asysnchrony cycles with electric impedance tomography measurements
Time Frame: during mechanical ventilation
connecting machine learning assessed patient-ventilator asynchrony respiratory cycles with the inherent respiratory cycle recorded by the electric impedance tomography
during mechanical ventilation
identifying unic electric impedance tomography signs of asynchrony
Time Frame: during mechanical ventilation
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
during mechanical ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

Collaborators

Szeged University
Budapest University of Technology and Economics
Hochschule Furtwangen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 12, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAVELA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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