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NCT Number: NCT06377449

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

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.

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Key information

Conditions

Ischemic Heart Disease Aneurysm Aneurysm, Ascending Aorta Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Insufficiency Aortic Stenosis, Severe Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Ascending Aortic Aneurysm Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Insufficiency Mitral Stenosis Mitral Stenosis With Insufficiency Mitral Valve Insufficiency Mitral Valve Stenosis Myocardial Ischemia Tricuspid Insufficiency Tricuspid Valve Insufficiency Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Petersburg State University Clinic

Saint Petersburg, Sankt-Peterburg, 190020, Russia

Location status: Recruiting

Location contact

Sergei M Efremov, MD, PhD

CONTACT

[email protected]

+79137946090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Postoperative pulmonary complications

    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

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

  2. Cumulative dosage of diuretics

    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

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

  3. Number of nights at home after 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksei A Filippov, MD, PhD

CONTACT

[email protected]

+79819553639

Sergey M Efremov, MD, PhD

CONTACT

[email protected]

+79137946090

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 22, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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