Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FOU2024-00038 | Registry Identifier | Forskning och Utveckling (Region Uppsala) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Ultrasound | Experimental | Lung ultrasound based on specified protocol as primary method of investigation |
|
| Routine Care | No Intervention | Routine care defined as conventional chest x-ray as primary method of investigation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Ultrasound | Diagnostic Test | Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Delayed removal of chest tube |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Inter-rater variability |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laila Hellgren-Johansson, PhD | Region Uppsala | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala Akademiska sjukhuset | Uppsala | Uppland | 751 85 | Sweden |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2024 | Feb 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2024 | Apr 1, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2024 | Feb 7, 2024 | ICF_001.pdf |
Not provided
Case-Control
Not provided
Not provided
Inter-rater variability will be masked.
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, in hours, to eventual removal of chest tube | Through patient hospital stay, an average of five days |
| 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 |
Inter-observer agreement study of collected ultrasound images.
| Through patient hospital stay, an average of five days |