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

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease; Aortic Stenosis, Severe; Aortic Insufficiency; Mitral Stenosis; Mitral Insufficiency; Mitral Stenosis with Insufficiency; Tricuspid Insufficiency; Ascending Aortic Aneurysm
• Interventions: Diagnostic Test: Ultrasound examination of the lungs

• Registration Number: NCT06377449
• Lead Sponsor: Saint Petersburg State University, Russia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Study Start: 2024-05-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-05-15
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical management based on results of ultrasound lungs examination	Ultrasound examination of the lungs	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.
Medical management based on routine clinical and X-ray diagnostic methods	Ultrasound examination of the lungs	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.

Primary Outcome Measures

Name	Time	Method
The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination	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	Participants with more than three B-lines according to ultrasound lung examination (BLUE protocol) at the day of hospital discharge

Secondary Outcome Measures

Name	Time	Method
Cumulative dosage of diuretics	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	Cumulative dosage of administered diuretic drugs will be calculated for each patient in both groups
Number of nights at home after 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	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
Postoperative pulmonary complications	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	Presence of any pulmonary complications (e.g. pleural effusion, pneumothorax, pulmonary edema, atelectasis, pneumonia) during postoperative hospital period will be analyzed

Trial Locations

Locations (1)

Saint Petersburg State University Clinic; 🇷🇺 Saint Petersburg, Russian Federation