Aortic Insufficiency, Aortic Stenosis, Severe, Ascending Aortic Aneurysm, Ischemic Heart Disease, Mitral Insufficiency, Mitral Stenosis, Mitral Stenosis with Insufficiency, Tricuspid Insufficiency
Conditions
Keywords
Ultrasound examination of the lungs, B-lines, Coronary artery bypass grafting, Heart valve surgery, Cardiopulmonary bypass, On-pump cardiac surgery
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.
Interventions
DIAGNOSTIC_TESTUltrasound 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
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Russia
Contacts
Primary ContactAleksei A Filippov, MD, PhD
Backup ContactSergey M Efremov, MD, PhD
Outcome results
None listed