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

Saint Petersburg State University, Russia

Status: Enrolling

Conditions: Ischemic Heart Disease; Tricuspid Insufficiency; Aortic Stenosis, Severe; Mitral Insufficiency; Ascending Aortic Aneurysm; Aortic Insufficiency; Mitral Stenosis with Insufficiency; Mitral Stenosis

Treatments: Diagnostic Test: Ultrasound examination of the lungs

Study type: Interventional

Funder types: Other

Identifiers

NCT06377449

UIL-CSP-18052023

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups

Medical management based on results of ultrasound lungs examination

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ultrasound examination of the lungs

Medical management based on routine clinical and X-ray diagnostic methods

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Ultrasound examination of the lungs