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The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question[s] it aims to answer are:
Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical management based on results of ultrasound lungs examination | Experimental | Based on the degree/ presence of interstitial pulmonary edema (number of B-lines) and presence of postoperative pleural effusion, identified by regularly performed ultrasound examination of the lungs, medical therapy will be modified in each particular patient to improve clinical status and outcome. Administration of the following drug groups can be made/ doses can be adjusted: Diuretics (furosemide/ Hypothiazide/ spironolactone), Non-steroid antiinflammatory (Ibuprofen), Glucocorticoids. |
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| Medical management based on routine clinical and X-ray diagnostic methods | Active Comparator | Ultrasound examination of the lungs will be performed in all patients in this group, but the attending physician will not be informed about it's results and findings. Any changes in medical therapy/ treatment strategy will be based on standard clinical and X-ray diagnostic methods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound examination of the lungs | Diagnostic Test | Experimental: Standard ultrasound examination of the lungs based on modified BLUE protocol Active Comparator: Standard ultrasound examination of the lungs based on modified BLUE protocol |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination | Participants with more than three B-lines according to ultrasound lung examination (BLUE protocol) at the day of hospital discharge | Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complications | Presence of any pulmonary complications (e.g. pleural effusion, pneumothorax, pulmonary edema, atelectasis, pneumonia) during postoperative hospital period will be analyzed | Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksei A Filippov, MD, PhD | Contact | +79819553639 | aleksei.filippov.chb@gmail.com | |
| Sergey M Efremov, MD, PhD | Contact | +79137946090 | sergefremov@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Petersburg State University Clinic | Recruiting | Saint Petersburg | Sankt-Peterburg | 190020 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14695718 | Background | Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006. | |
| 34191132 | Result | Russell FM, Ehrman RR, Barton A, Sarmiento E, Ottenhoff JE, Nti BK. B-line quantification: comparing learners novice to lung ultrasound assisted by machine artificial intelligence technology to expert review. Ultrasound J. 2021 Jun 30;13(1):33. doi: 10.1186/s13089-021-00234-6. |
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Individual participant data is not planned to be shared with other parties
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Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)
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| Cumulative dosage of diuretics | Cumulative dosage of administered diuretic drugs will be calculated for each patient in both groups | Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks |
| Number of nights at home after hospital discharge | During 30 days after hospital discharge, the number of nights at home without any additional medical aid due to pulmonary complications, will be found for each patient | Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| D000094625 | Aneurysm, Ascending Aorta |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |
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