Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients

Ischemic Heart Disease Clinical Trial

Official title:

Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377449
• Other study ID #: UIL-CSP-18052023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Saint Petersburg State University, Russia
• Contact: Aleksei A Filippov, MD, PhD
• Phone: +79819553639
• Email: aleksei.filippov.chb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Insufficiency
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Ascending Aortic Aneurysm
• Constriction, Pathologic
• Coronary Artery Disease
• Ischemic Heart Disease
• Mitral Insufficiency
• Mitral Stenosis
• Mitral Stenosis With Insufficiency
• Mitral Valve Insufficiency
• Mitral Valve Stenosis
• Myocardial Ischemia
• Tricuspid Insufficiency
• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Russian Federation	Saint Petersburg State University Clinic	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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

Outcome

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