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

ConditionsIschemic Heart DiseaseAortic Stenosis, SevereAortic InsufficiencyMitral StenosisMitral InsufficiencyMitral Stenosis With InsufficiencyTricuspid InsufficiencyAscending Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024

signed informed consent for participation in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Medical management based on results of ultrasound lungs examinationExperimental treatment 1 intervention
Group B: Medical management based on routine clinical and X-ray diagnostic methodsActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Postoperative pulmonary complications

Presence of any pulmonary complications (e.g. pleural effusion, pneumothorax, pulmonary edema, atelectasis, pneumonia) during postoperative hospital period will be analyzed

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
2

Cumulative dosage of diuretics

Cumulative dosage of administered diuretic drugs will be calculated for each patient in both groups

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
3

Number of nights at home after hospital discharge

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Petersburg State University, Russia

Lead sponsor

Source ClinicalTrials.gov
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