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NCT Number: NCT06261411

Lung Ultrasound as Alternative to Radiography in Thoracic Surgery

This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.

Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala Akademiska sjukhuset

Uppsala, Uppland, 751 85, Sweden

About this study

Modern lung surgery involves a variety of procedures that expose patients to the risk of developing postoperative complications (PPC). In lung surgery such as resections or lobectomies where a part of the lung tissue is removed, so-called single-lung ventilation is used. Through this technique, the lung that is operated on collapses, while ventilation is directed to the lung that is not operated on. When the operation is over, the structures of the lung are sewn together and the collapsed lung is inflated again. At this stage, it is important to ensure that the expansion of the lung is adequate. It is also important for the continued expansion of the lung that there is no air leakage from the lung to the pleural cavity. Therefore, there is initially a drainage in the pleural cavity to prevent both bleeding and air leakage. Postoperatively, several X-ray examinations are performed before the patient is discharged to ensure adequate lung expansion.

Lung ultrasound is a well-established method that is based on physical artifacts that arise in the interaction between ultrasound and various conditions in the lung tissue. The method is used in most of the questions that are usually asked even in chest X-rays and other conventional techniques but has the advantages of being both cost- and time-effective and does not involve the radiation dose that conventional X-rays involve.

The study aims to investigate whether lung ultrasound can replace conventional chest X-rays in patients who have undergone lung surgery. The research subjects will be randomized to undergo postoperative lung ultrasound or conventional chest X-rays after lung surgery.

Previous research has shown the possibility of abandoning X-ray radiation in favor of ultrasound in most scenarios. However, randomized studies are generally lacking, especially in this population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Segmental, partial, or wedge resection lung surgery, or lobectomy.
  • Written informed consent
  • Available research team for measurements.

Exclusion criteria

  • Pregnancy
  • Re-surgery due to complications related to the original surgery
  • Need for critical care or admittance to the ICU.
  • Patient or physician choice of withdrawal from the study

Treatment and study plan

Lung Ultrasound

Diagnostic Test

Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma.

Other names: LUS

Primary outcomes

  1. Reduction in chest x-ray

    Time frame: Through patient hospital stay, an average of five days

    Reduction in chest x-ray in patients undergoing thoracic surgery when LUS is the primary method of investigation.

Secondary outcomes

  1. Re-insertion of chest tube

    Time frame: Through patient hospital stay, an average of five days

    The need for re-insertion och chest tube because of clinical deterioration, and/or verified clinically relevant post-operative pulmonary complication

  2. Delayed removal of chest tube

    Time frame: Through patient hospital stay, an average of five days

    Number of patients in need of prolonged care with chest tube.

  3. Time to chest tube removal

    Time frame: Through patient hospital stay, an average of five days

    Time, in hours, to eventual removal of chest tube

  4. Patient Satisfaction

    Time frame: Through patient hospital stay, an average of five days

    Sub-group analysis of the patient experience and satisfaction for patients receiving both lung ultrasound and chest x-ray, measures through quantitative psychometric questionnaire with Likert-design consisting of a minimum value of 1 and a maximum of 5. Worse outcome is associated with low scores and vice versa.

Other outcomes

  1. Missed Care

    Time frame: Through patient hospital stay, an average of five days

    The number of missed diagnoses of post-operative pulmonary complications based on results from chest x-ray in patients subjected to group crossover.

  2. Inter-rater variability

    Time frame: Through patient hospital stay, an average of five days

    Inter-observer agreement study of collected ultrasound images.

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Official study title

Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial

Acronym: LUS-ART

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Apr 29, 2025

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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