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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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