Thoracic SurgeryLUS-ARTNCT06261411
Lung Ultrasound as Alternative to Radiography in Thoracic Surgery
A study testing Lung Ultrasound in people with Thoracic Surgery and Ultrasonography, run by Uppsala University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Ultrasonography
- What is being tested?
- Lung Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 12 Feb 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Segmental, partial, or wedge resection lung surgery, or lobectomy.
- Written informed consent
- Available research team for measurements.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Thoracic Surgery, Ultrasonography
- Being tested
- Lung Ultrasound
- Keywords
- Thoracic surgery, Lung ultrasound, Chest X-ray, Nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
Also called LUS
Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma.
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound | Experimental | Lung ultrasound based on specified protocol as primary method of investigation Receives: Diagnostic Test: Lung Ultrasound |
| Routine Care | No intervention | Routine care defined as conventional chest x-ray as primary method of investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in chest x-ray
Reduction in chest x-ray in patients undergoing thoracic surgery when LUS is the primary method of investigation.
Measured: Through patient hospital stay, an average of five days
Secondary outcomes (4)
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
Measured: Through patient hospital stay, an average of five days
Delayed removal of chest tube
Number of patients in need of prolonged care with chest tube.
Measured: Through patient hospital stay, an average of five days
Time to chest tube removal
Time, in hours, to eventual removal of chest tube
Measured: 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.
Measured: Through patient hospital stay, an average of five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start12 Feb 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-Control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Ullmark, Uppsala University Hospital
- Investigators
- Laila Hellgren-Johansson, PhD, Study director, Region Uppsala Public Health and Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261411
- Sponsor's protocol ID
- 999430
- Other IDs
- FOU2024-00038
- Acronym
- LUS-ART
- Status last verified
- Apr 2025
- First submitted
- 30 Jan 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06261411
- Acronym / sponsor ID
- LUS-ART / 999430
- Conditions
- Thoracic Surgery, Ultrasonography
- Keywords
- Thoracic surgery, Lung ultrasound, Chest X-ray, Nurse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Case-Control
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound | Experimental | Diagnostic Test: Lung UltrasoundLung 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Segmental, partial, or wedge resection lung surgery, or lobectomy.
- Written informed consent
- Available research team for measurements.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasoundAlso: LUSDiagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma. | Diagnostic test | Lung Ultrasound |
Primary outcome
Reduction in chest x-ray
Time frame: 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.
4 secondary outcomes
Re-insertion of chest tube
Time frame: Through patient hospital stay, an average of five days
Delayed removal of chest tube
Time frame: Through patient hospital stay, an average of five days
Time to chest tube removal
Time frame: Through patient hospital stay, an average of five days
Patient Satisfaction
Time frame: Through patient hospital stay, an average of five days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila Hellgren-Johansson, PhD study director
Region Uppsala Public Health and Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Ultrasound in people with Thoracic Surgery and Ultrasonography, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in chest x-ray (time frame: Through patient hospital stay, an average of five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.