Clinical trial NCT06261411: Lung Ultrasound as Alternative to Radiography in Thoracic Surgery
Official title: Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Ultrasonography
Keywords: Thoracic surgery
Lung ultrasound
Chest X-ray
Nurse
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-Control
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in chest x-ray
timeFrame: Through patient hospital stay, an average of five days
Secondary outcomes:
measure: Re-insertion of chest tube
timeFrame: Through patient hospital stay, an average of five days
measure: Delayed removal of chest tube
timeFrame: Through patient hospital stay, an average of five days
measure: Time to chest tube removal
timeFrame: Through patient hospital stay, an average of five days
measure: Patient Satisfaction
timeFrame: Through patient hospital stay, an average of five days
Other outcomes:
measure: Missed Care
timeFrame: Through patient hospital stay, an average of five days
measure: Inter-rater variability
timeFrame: Through patient hospital stay, an average of five days
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Akademiska sjukhuset
state: Uppland
Study officials:
affiliation: Region Uppsala
name: Laila Hellgren-Johansson, PhD
role: STUDY_DIRECTOR
References: