Lung Ultrasound vs Chest X-ray for Collapsed Lung

(LUSvsCXR Trial)

Overseen By Lilia Kaustov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pneumothorax, Mechanical ventilation, Emphysema

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether lung ultrasound (LUS) detects a collapsed lung (pneumothorax) more effectively than chest X-rays after chest tube removal. Doctors believe LUS might provide a safer and more comfortable diagnostic method. The trial compares both methods to determine which offers a more accurate diagnosis. Individuals who have undergone cardiac surgery or experienced trauma and recently had a chest tube removed may qualify for this study. As an unphased trial, it offers participants the opportunity to contribute to research that could enhance patient comfort and safety in the future.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that lung ultrasound is safe for diagnosing pneumothorax?

Research has shown that lung ultrasound (LUS) safely and effectively diagnoses a collapsed lung, or pneumothorax. Studies have found that LUS exposes patients to less radiation than chest X-rays, making it a safer choice. LUS is not only safer but also faster and less painful. One study found that medical trainees could successfully use LUS to detect a collapsed lung after certain surgeries.

Overall, LUS is well-tolerated and has no known side effects. As a non-invasive procedure, it doesn't require inserting anything into the body, which further reduces risks. This makes LUS a promising alternative to chest X-rays for diagnosing collapsed lungs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lung ultrasound (LUS) for detecting a collapsed lung because it could be a faster and safer alternative to the traditional chest X-ray (CXR). Unlike CXR, LUS doesn't expose patients to radiation, making it a safer choice, especially for repeated use. Additionally, LUS can be performed at the bedside, offering quicker results and potentially speeding up diagnosis and treatment. This method could make the process more efficient and comfortable for patients, leading to better overall care.

What evidence suggests that lung ultrasound is effective for diagnosing pneumothorax?

Research has shown that lung ultrasound (LUS) effectively diagnoses a collapsed lung, known as pneumothorax. One study demonstrated its reliability by correctly identifying 90 out of 100 cases. Unlike chest X-rays, LUS is safer, less expensive, and not painful. It aids doctors in making quick and accurate decisions, crucial in emergencies. In this trial, participants will undergo both a chest X-ray and LUS in a predetermined order to compare their effectiveness in diagnosing pneumothorax after chest tube removal. Thus, LUS appears to be a promising method for diagnosing pneumothorax. ^{1 2 6 7 8}

Who Is on the Research Team?

Jacobo Moreno Garijo, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a chest tube removed recently after cardiac surgery or trauma. It's not for those with prior pneumothorax needing intervention, on ventilators, or with subcutaneous emphysema affecting ultrasound visibility.

Inclusion Criteria

I recently had a chest tube removed.

Exclusion Criteria

I have air trapped under my skin because it's hard to see my lung lining.

I needed treatment for a lung collapse before having a chest tube removed.

You are currently using a ventilator to help you breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Assessment

Participants undergo diagnostic assessment using both chest X-ray (CXR) and lung ultrasound (LUS) for pneumothorax detection post-chest tube removal

12 months

Sequential assessments (CXR followed by LUS)

Follow-up

Participants are monitored for safety and effectiveness of diagnostic methods

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lung Ultrasound

Trial Overview The study compares lung ultrasound (LUS) to chest X-rays (CXR) in detecting pneumothorax after chest tube removal. Medical trainees will perform LUS to see if it's more accurate and reliable than the traditional CXR method.

How Is the Trial Designed?

Group I: Diagnostic modalities comparison Experimental Treatment 1 Intervention

All participants belong to a single arm. A chest X-ray (CXR) and lung ultrasound (LUS) in a predetermined order (CXR followed by LUS), will be performed sequentially for pneumothorax (PNX) detection after chest/mediastinal tube removal. There is no control group or randomization.

Lung Ultrasound is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Lung Ultrasound for:

• Diagnosis of pneumothorax
• Detection of pleural effusion
• Evaluation of lung abnormalities

Approved in United States as Lung Ultrasound for:

• Diagnosis of pneumothorax
• Detection of pleural effusion
• Evaluation of lung abnormalities

Approved in Canada as Lung Ultrasound for:

• Diagnosis of pneumothorax
• Detection of pleural effusion
• Evaluation of lung abnormalities

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Lung ultrasound (LUS) is widely used in Italian ICUs, with 94.3% of participating units performing it, primarily by internal intensivists, but the frequency of use is low, averaging less than one test per bed per week.

Only 11% of ICUs have a standardized reporting format for LUS, indicating a need for improved protocols to enhance the consistency and effectiveness of this diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current adoption of lung ultrasound in Intensive Care Units: an Italian multi-center survey. Calamai, I., Greco, M., Bertolini, G., et al.[2019]

A short 9-hour training course in lung ultrasound (LUS) for 19 medical doctors resulted in excellent proficiency in recognizing key signs related to acute respiratory failure, particularly for interstitial syndrome and pleural effusion.

LUS significantly influenced patient management, with changes in therapy for 16 patients and immediate management adjustments for 9 patients, highlighting its potential as a valuable tool in Internal Medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound in internal medicine: training and clinical practice. Mozzini, C., Fratta Pasini, AM., Garbin, U., et al.[2022]

Lung ultrasound (LUS) effectively identified various abnormalities in hospitalized COVID-19 patients, showing a strong correlation with chest CT findings (rho = 0.70), which suggests it can be a reliable diagnostic tool for assessing pneumonia severity.

The study established a LUS severity score cut-off of ≥27, which indicates severe pulmonary involvement, demonstrating high sensitivity (88.5%) and specificity (97%) when compared to CT results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-center comparative study of lung ultrasound versus chest computed tomography during the COVID-19 era. Zhanna Davidovna, K., Fuad Safarova, A., Cabello Montoya, FE., et al.[2022]

Lung ultrasound (LUS) is a safe and effective tool for diagnosing respiratory diseases in neonates, as it can be performed at the bedside without the risks associated with radiation.

LUS findings are consistent and repeatable across various neonatal respiratory conditions, making it a valuable extension of the clinical examination for real-time diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound: diagnostic and therapeutic issues. Cattarossi, L.[2018]

Implementing lung ultrasound (LUS) as the first-line imaging technique for newborns with respiratory distress significantly reduced the number of chest X-rays (CXR) performed, leading to lower radiation exposure per infant.

The use of LUS did not negatively impact clinical outcomes, as respiratory support needs and complications remained similar between the two groups, indicating that LUS is a safe and effective alternative to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound protocol decreases radiation in newborn population without side effects: A quality improvement project. Rodriguez-Fanjul, J., Benet, N., Rodrigo Gonzalo de Lliria, C., et al.[2023]

Lung ultrasound (LUS) has been validated as a reliable tool for early diagnosis and treatment evaluation in patients with acute respiratory distress syndrome (ARDS), making it useful for both pediatric and adult populations.

LUS is a noninvasive, radiation-free, and cost-effective method that can aid in managing ARDS in the Intensive Care Unit, although its effectiveness in predicting patient responses to certain treatments remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound: Predictor of acute respiratory distress syndrome in intensive care unit patients. Zhou, Y., Fan, Q., Cavus, O., et al.[2022]

Lung ultrasound (LUS) demonstrated high diagnostic accuracy for pleural effusion and lung consolidation in mechanically ventilated adults, with sensitivities of 91% and 92%, respectively, compared to chest radiographs (CXR) which had much lower sensitivities of 42% and 53%.

LUS also showed similar specificity (92%) for both pleural effusion and lung consolidation, making it a more reliable diagnostic tool than CXR in intensive care settings, based on a meta-analysis of five studies involving 253 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound has greater accuracy than conventional respiratory assessment tools for the diagnosis of pleural effusion, lung consolidation and collapse: a systematic review. Hansell, L., Milross, M., Delaney, A., et al.[2022]

Lung ultrasound (LUS) is a safe and effective bedside tool for diagnosing and monitoring neonatal and pediatric respiratory diseases, as it does not involve radiation and allows for immediate interpretation of results.

LUS reveals distinct and reproducible patterns in various lung diseases, making it a valuable extension of the clinical examination that should be performed by the treating clinician for optimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound: its role in neonatology and pediatrics. Cattarossi, L.[2016]

Lung ultrasound (LU) is widely used in 82% of Italian neonatal intensive care units (NICUs) as a noninvasive diagnostic tool for various respiratory conditions, with pneumothorax and respiratory distress syndrome being the most common applications.

Despite its popularity, the use of LU varies significantly across centers, highlighting the need for standardized clinical guidelines and formal training programs to ensure consistent and effective use of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound in Italian neonatal intensive care units: A national survey. Corsini, I., Parri, N., Ficial, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11941729/

Lung Ultrasound in Critical Care: A Narrative Review - PMC Lung ultrasound (LUS) has become a crucial part of the investigative tools available in the management of critically ill patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3734893/

Relevance of Lung Ultrasound in the Diagnosis of Acute ... Lung ultrasound can help the clinician make a rapid diagnosis in patients with acute respiratory failure, thus meeting the priority objective of saving time.

3. link.springer.com link.springer.com/article/10.1007/s40477-025-00998-w

Value of focused lung ultrasound in diagnosing and ... Ultrasound can be used to diagnose pneumothorax after CT-guided lung biopsy. All pneumothoraxes that were identified by ultrasound were detected within the ...

4. publications.ersnet.org publications.ersnet.org/content/errev/25/141/230

The efficacy of bedside chest ultrasound: from accuracy to ... However, there is a paucity of evidence for outcome efficacy of chest ultrasound in relation to parenchymal lung disorders and musculoskeletal conditions.

5. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01123-6

Feasibility and efficacy of lung ultrasound to investigate ... LUS was reliable in diagnosing atelectasis (sensitivity 98.0%, specificity 96.7% and diagnostic accuracy 97.2%), pneumothorax (sensitivity 90.0% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07018856

Feasibility Study of Novice-Performed Lung Ultrasound for ... This is a feasibility study to test whether lung ultrasound can be used by medical trainees to detect pneumothorax (collapsed lung) after heart surgery, instead ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05102-y

Nuts and bolts of lung ultrasound: utility, scanning techniques ... Lung ultrasound to detect pneumothorax in children evaluated for acute chest pain in the emergency department: an observational pilot study.

8. aium.org aium.org/resources/official-statements/view/statement-and-recommendations-for-safety-assurance-in-lung-ultrasound

Statement and Recommendations for Safety Assurance in ... A neonatal LUS safety preset incorporating a limit of MI≤0.3 should be pre-installed on all ultrasound machines.