Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
NCT ID: NCT06377449
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
186 participants
INTERVENTIONAL
2024-05-15
2026-01-01
Brief Summary
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* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.
* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Medical management based on results of ultrasound lungs examination
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.
Ultrasound examination of the lungs
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
Medical management based on routine clinical and X-ray diagnostic methods
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.
Ultrasound examination of the lungs
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
Interventions
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Ultrasound examination of the lungs
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
Eligibility Criteria
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Inclusion Criteria
* signed informed consent for participation in the study
Exclusion Criteria
* surgical procedures on lungs and lung cancer in the anamnesis
* chronic obstructive pulmonary disease, stage III
* chronic kidney disease, stages 4 and 5
* patients with low Risk Score profile by the Society of Thoracic Surgeons
18 Years
ALL
No
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Filippov Aleksei, MD, PhD
State Cardiovascular Surgeon
Locations
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Saint Petersburg State University Clinic
Saint Petersburg, Sankt-Peterburg, Russia
Countries
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Central Contacts
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Facility Contacts
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Sergei M Efremov, MD, PhD
Role: primary
References
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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.
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.
Other Identifiers
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UIL-CSP-18052023
Identifier Type: -
Identifier Source: org_study_id