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

NCT06377449 | Recruiting

• 1 other identifier: UIL-CSP-18052023
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Medical management based on results of ultrasound lungs examination

EXPERIMENTAL

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.

Diagnostic Test: Ultrasound examination of the lungs

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

ACTIVE COMPARATOR

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.

Diagnostic Test: Ultrasound examination of the lungs

Interventions

Ultrasound examination of the lungs DIAGNOSTIC_TEST

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

Medical management based on results of ultrasound lungs examination; Medical management based on routine clinical and X-ray diagnostic methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024
• signed informed consent for participation in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Clinic

Saint Petersburg, Sankt-Peterburg, 190020, Russia

RECRUITING

Related Publications (2)

• 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.

  PMID: 34191132 BACKGROUND

• 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.

  PMID: 14695718 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Aneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Aortic Diseases

Central Study Contacts

Aleksei A Filippov, MD, PhD

CONTACT

+79819553639; aleksei.filippov.chb@gmail.com

Sergey M Efremov, MD, PhD

CONTACT

+79137946090; sergefremov@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: State Cardiovascular Surgeon

Model Details: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms)

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: April 22, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: January 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)