Lung Ultrasound vs Chest X-ray for Collapsed Lung

(LUSvsCXR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jacobo Moreno Garijo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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.

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 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 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}

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.

I am 18 years old or older.

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.

Treatment Details

Interventions

• Lung Ultrasound (Procedure)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sunnybrook Health Science Centre Toronto, Canada

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre Lead Sponsor

References

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

Current adoption of lung ultrasound in Intensive Care Units: an Italian multi-center survey. [2019] Lung ultrasound (LUS) is a useful tool for assessing lung status in critically ill patients, but is not widely applied in intensive care units (ICUs). The aim of this study was to investigate the use of LUS in Italian ICUs.

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

Lung ultrasound: diagnostic and therapeutic issues. [2018] Lung ultrasound (LUS) is becoming more and more utilised in the clinical field inadults, children and neonates in course of respiratory diseases. It can be done at bed side and repeated as muchis needed without risks (namely irradiation).

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] In mechanically ventilated adults in intensive care, what is the accuracy of lung ultrasound (LUS) for the diagnosis of pleural effusion, lung consolidation and lung collapse when compared with chest radiograph (CXR) and lung auscultation, with computed tomography (CT) as the reference standard?

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

Lung ultrasound in internal medicine: training and clinical practice. [2022] Lung ultrasound (LUS) represents an emerging technique for bedside chest imaging in different clinical settings. A standardized approach allows the diagnosis, the quantification, and the follow-up of different conditions for which acute respiratory failure is the main clinical presentation. The aim of this study was to test what skill targets could be achieved in LUS, with a short-training course offered to 19 Medical Doctors attending the certification board school in Internal Medicine at the University of Verona, Italy.

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

Lung ultrasound: Predictor of acute respiratory distress syndrome in intensive care unit patients. [2022] The purpose of the study was to review and summarize current literature concerning the validation and application of lung ultrasound (LUS) in critically ill patients with acute respiratory distress syndrome (ARDS).

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

Lung ultrasound in Italian neonatal intensive care units: A national survey. [2022] Lung ultrasound (LU) is a noninvasive, bedside imaging technique that is attracting growing interest in the evaluation of neonatal respiratory diseases. We conducted a nationwide survey of LU usage in Italian neonatal intensive care units (NICUs).

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

Lung ultrasound protocol decreases radiation in newborn population without side effects: A quality improvement project. [2023] To reduce radiation exposure in newborns admitted due respiratory distress based on the implementation of lung ultrasound (LUS).

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

Lung ultrasound: its role in neonatology and pediatrics. [2016] Lung ultrasound (LUS) has become more and more popular in the first decade of the 21(st) century, both in neonatal and in pediatric age groups. Several papers addressed the usefulness of this procedure mainly because of its possibility to be utilised at the bedside, without risk of irradiation along with simple and immediate interpretations of the images.

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] Lung ultrasound (LUS) is a bedside imaging tool that has proven useful in identifying and assessing the severity of pulmonary pathology. The aim of this study was to determine LUS patterns, their clinical significance, and how they compare to CT findings in hospitalized patients with coronavirus infection.