Clinical trial NCT06377449: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
Official title: Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Aortic Stenosis, Severe
Aortic Insufficiency
Mitral Stenosis
Mitral Insufficiency
Mitral Stenosis with Insufficiency
Tricuspid Insufficiency
Ascending Aortic Aneurysm
Keywords: Ultrasound examination of the lungs
B-lines
Coronary artery bypass grafting
Heart valve surgery
Cardiopulmonary bypass
On-pump cardiac surgery
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination
timeFrame: 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 outcomes:
measure: Postoperative pulmonary complications
timeFrame: 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
measure: Cumulative dosage of diuretics
timeFrame: 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
measure: Number of nights at home after hospital discharge
timeFrame: 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
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State University Clinic
Study officials:
References:
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: 10.1186/s13089-021-00234-6.
citation: 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.