Lung Ultrasound as Alternative to Radiography in Thoracic Surgery (LUS-ART)
Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Uppland
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Uppsala, Uppland, Sweden, 751 85
- Uppsala Akademiska sjukhuset
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lung Ultrasound
Lung ultrasound based on specified protocol as primary method of investigation
|
Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma.
Other Names:
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No Intervention: Routine Care
Routine care defined as conventional chest x-ray as primary method of investigation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through patient hospital stay, an average of five days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Through patient hospital stay, an average of five days
|
|
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.
|
Through patient hospital stay, an average of five days
|
|
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
|
Through patient hospital stay, an average of five days
|
|
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.
|
Through patient hospital stay, an average of five days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through patient hospital stay, an average of five days
|
|
Inter-rater variability
Time Frame: Through patient hospital stay, an average of five days
|
Inter-observer agreement study of collected ultrasound images.
|
Through patient hospital stay, an average of five days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Laila Hellgren-Johansson, PhD, Region Uppsala
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999430
- FOU2024-00038 (Registry Identifier: Forskning och Utveckling (Region Uppsala))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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