Preeclampsia Clinical Trial
Official title:
Evaluation of Artificial Intelligence in Defining Lung Ultrasound Findings in Anesthesia Management of Preeclampsia
NCT number | NCT05487014 |
Other study ID # | 202 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | July 26, 2022 |
Verified date | August 2022 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 26, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selin Bagcaz | Çankaya | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | For comparison, artificial intelligence assisted ultrasound and standard ultrasound in the follow-up of 35 preeclamptic parturients will be performed. | 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 |
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