Lung Ultrasound as Alternative to Radiography in Thoracic Surgery

Not Applicable

Active, not recruiting

• Conditions: Thoracic Surgery; Ultrasonography
• Interventions: Diagnostic Test: Lung Ultrasound

• Registration Number: NCT06261411
• Lead Sponsor: Uppsala University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-07
• Study Start: 2024-02-12
• Study First Posted: 2024-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Ultrasound	Lung Ultrasound	Lung ultrasound based on specified protocol as primary method of investigation

Primary Outcome Measures

Name	Time	Method
Reduction in chest x-ray	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 Outcome Measures

Name	Time	Method
Re-insertion of chest tube	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
Delayed removal of chest tube	Through patient hospital stay, an average of five days	Number of patients in need of prolonged care with chest tube.
Time to chest tube removal	Through patient hospital stay, an average of five days	Time, in hours, to eventual removal of chest tube
Patient Satisfaction	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.

Trial Locations

Locations (1)

Uppsala Akademiska sjukhuset; 🇸🇪 Uppsala, Uppland, Sweden