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

60 Participants Needed

Trial Summary

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 data supports the idea that Lung Ultrasound vs Chest X-ray for Collapsed Lung is an effective treatment?

The available research shows that Lung Ultrasound (LUS) is more accurate than Chest X-ray for diagnosing lung collapse, as well as other lung issues like fluid buildup and lung tissue thickening. This means LUS can help doctors identify problems more reliably. Additionally, LUS can be done at the patient's bedside and repeated as needed without any risk of radiation, making it a safer option compared to Chest X-rays. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Lung Ultrasound (LUS) for collapsed lung?

Research shows that Lung Ultrasound (LUS) is more accurate than traditional methods like chest X-rays for diagnosing lung issues such as pleural effusion (fluid around the lungs), lung consolidation (lung tissue filled with liquid), and lung collapse, especially in critically ill patients. ^{1 2 3 4 5}

What safety data exists for lung ultrasound in treating collapsed lung?

Lung ultrasound (LUS) is considered safe as it can be performed at the bedside and repeated as needed without the risk of radiation exposure. Studies highlight its noninvasive nature and its growing use in various clinical settings, including neonatal and pediatric care, without reported side effects. ^{1 2 6 7 8}

Is lung ultrasound safe for humans?

Lung ultrasound (LUS) is considered safe for humans as it can be done at the bedside and repeated as needed without risks like radiation exposure. ^{1 2 6 7 8}

Is Lung Ultrasound a promising treatment for a collapsed lung compared to a chest X-ray?

Yes, Lung Ultrasound is a promising treatment for a collapsed lung. It is a noninvasive and bedside imaging technique that is gaining popularity for its accuracy in diagnosing lung issues like lung collapse. Studies show that it can be more accurate than traditional methods like chest X-rays in certain cases. ^{1 3 4 6 9}

How does lung ultrasound differ from other treatments for a collapsed lung?

Lung ultrasound (LUS) is a unique, noninvasive bedside imaging technique that provides real-time assessment of lung conditions, making it more accessible and safer compared to traditional chest X-rays or CT scans, which involve radiation exposure. LUS is particularly useful in critically ill patients and can be performed quickly at the patient's bedside, offering immediate insights into lung status without the need for patient transport. ^{1 3 4 6 9}

What is the purpose of this trial?

Sunnybrook Health Sciences Center annually provides assistance to approximately 600 cardiac surgeries and 1500 trauma patients, many of whom require chest tubes to prevent blood and fluids from accumulating in the pleural cavities surrounding the heart. During the removal of chest tubes, there is a risk of air leaking into these cavities, leading to pneumothorax, a critical condition occurring in approximately 5-26% of cases, associated with increased complications and mortality. Currently, the diagnosis of pneumothorax is primarily based on chest X-rays (CXR), despite their limitations and low reliability. As an alternative method, lung ultrasound (LUS) offers several advantages: it is safer, less expensive, and less painful for patients compared to CXR. However, there is a lack of comparative data on the accuracy and interrater reliability of these two diagnostic approaches after chest tube removal. This study aims to evaluate the accuracy of lung ultrasound performed by medical trainees in diagnosing pneumothorax in cardiac and trauma patients. By comparing LUS to CXR, the investigators seek to determine if LUS provides a more reliable and precise diagnosis. This study has the potential to enhance patient care by establishing a more effective and accessible method for diagnosing pneumothorax post-chest tube removal.

Research Team

Jacobo Moreno Garijo, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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 (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]

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) 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 (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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Current adoption of lung ultrasound in Intensive Care Units: an Italian multi-center survey. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

Lung ultrasound: diagnostic and therapeutic issues. [2018]

3. Netherlands 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. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Lung ultrasound in internal medicine: training and clinical practice. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Lung ultrasound: Predictor of acute respiratory distress syndrome in intensive care unit patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Lung ultrasound in Italian neonatal intensive care units: A national survey. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Lung ultrasound protocol decreases radiation in newborn population without side effects: A quality improvement project. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

A single-center comparative study of lung ultrasound versus chest computed tomography during the COVID-19 era. [2022]