Artificial Intelligence in Lung Ultrasound for Preeclampsia

August 8, 2022 updated by: Berrin Gunaydin, Gazi University

Evaluation of Artificial Intelligence in Defining Lung Ultrasound Findings in Anesthesia Management of Preeclampsia

A total of eight quadrants of standard lung US examination was performed to all pregnant women with preeclampsia within the scope of the study by the same anesthesiologist, dividing each hemithorax into four regions through the parasternal, anterior axillary, posterior axillary vertical lines, and the horizontal line assumed to pass under the nipple. The resulting images were stored in digital media. A Lung US examination was performed once for an average of 5-10 minutes. The presence of B lines was investigated in the examination.

The case was defined as interstitial edema when the B lines, which are defined as vertical linear hyperechoic reverberation artifacts representing the edematous interlobular septa/alveoli, extend posteriorly from below the pleural line and moving in sync with lung movements, are found in two or more lung areas. B-lines were determined for each case and reported in standard form in terms of number and morphology. The diagnostic accuracy of B lines was determined with the artificial intelligence supported SmartAlpha Rievi 1300 software program. B-lines validated by artificial intelligence assisted algorithm in all stored digital images were reported blindly by another anesthesiologist experienced in lung US. The clinical features, laboratory parameters, and intraoperative hemodynamic data of the cases were recorded to be evaluated in terms of relationship with lung US data.

We predict that the application of lung US with artificial intelligence software will provide an opportunity to quickly evaluate the clinic of preeclamptic pregnant women who are frequently operated on in emergency conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

After ethics committee approval, standard lung ultrasound (US) examination in eight quadrants was performed to search presence of B lines in 35 ASA III-IV parturients with preeclampsia by the same anesthesiologist. Interstitial edema was defined by recognition of the B lines in two or more lung regions. The digital images of B-lines verified with artificial intelligence (AI) were evaluated blindly by another anesthesiologist experienced in lung US.

After assigning preeclamptic patients as mild or severe; demographic, hemodynamic and labarotary results were compared. Then, lung US findings (A pattern, 3 B lines and 1 or 2 B lines) were documented. Additionally, amount of protein / 24 hr, amount of fluid infusion (crystalloid or colloid) and hemodynamic parameters acording to lung US findings were compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

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

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey
        • Selin Bağcaz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

35 parturients who diagnosed with preeclampsia

Description

Inclusion Criteria:

  • Pregnant women who underwent cesarean section with a diagnosis of preeclampsia

Exclusion Criteria:

  • Preeclamptic parturients who have another lung disease
  • Preeclamptic parturients whose optimal lung US image could not be obtained

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
For comparison, artificial intelligence assisted ultrasound and standard ultrasound in the follow-up of 35 preeclamptic parturients will be performed.
Time Frame: Lung ultrasound application once in the preoperative period
If present, pulmonary edema will be diagnosed by visualising 3 B lines at least 2 or more regions
Lung ultrasound application once in the preoperative period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: D.Berrin Gunaydin, Prof., Gazi University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202

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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