Ischemic Heart Disease Clinical Trial
Official title:
Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
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: - 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.
Status | Not yet recruiting |
Enrollment | 186 |
Est. completion date | January 1, 2026 |
Est. primary completion date | May 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024 - signed informed consent for participation in the study Exclusion Criteria: - reoperations on the open heart with CPB - 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Saint Petersburg State University Clinic | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Saint Petersburg State University, Russia |
Russian Federation,
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. — View Citation
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: 10.11 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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