Lung Ultrasound as Alternative to Radiation in Thoracic Surgery

Thoracic Surgery Clinical Trial

— LUS-ART  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06261411
• Other study ID #: 999430
• Secondary ID: FOU2024-00038
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Surgery
• Ultrasonography

Intervention

Diagnostic Test:
• Lung Ultrasound
Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma.

Locations

Country	Name	City	State
Sweden	Uppsala Akademiska sjukhuset	Uppsala	Uppland

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Missed Care	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
Other	Inter-rater variability	Inter-observer agreement study of collected ultrasound images.	Through patient hospital stay, an average of five days
Primary	Reduction in chest x-ray	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	Re-insertion of chest tube	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
Secondary	Delayed removal of chest tube	Number of patients in need of prolonged care with chest tube.	Through patient hospital stay, an average of five days
Secondary	Time to chest tube removal	Time, in hours, to eventual removal of chest tube	Through patient hospital stay, an average of five days
Secondary	Patient Satisfaction	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