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Clinical Trials/NCT06377449
NCT06377449
Recruiting
Not Applicable

Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients

Saint Petersburg State University, Russia1 site in 1 country186 target enrollmentMay 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Heart Disease
Sponsor
Saint Petersburg State University, Russia
Enrollment
186
Locations
1
Primary Endpoint
The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2024
End Date
January 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saint Petersburg State University, Russia
Responsible Party
Principal Investigator
Principal Investigator

Filippov Aleksei, MD, PhD

State Cardiovascular Surgeon

Saint Petersburg State University, Russia

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

Outcomes

Primary Outcomes

The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

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