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| ID | Type | Description | Link |
|---|---|---|---|
| AFP2024-25-SB | Other Grant/Funding Number | Sunnybrook AFP Innovation Fund Grant 2024-25 |
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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Toronto General Hospital | OTHER |
| London Health Sciences Centre | OTHER |
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What is the purpose of this study? This study is being done to find out if medical trainees (such as residents and fellows) can learn to use lung ultrasound to detect a collapsed lung (pneumothorax) after heart surgery.
Who is participating in the study? Adults who have recently had heart surgery and are having their chest tubes removed in the intensive care unit may be able to join.
What will happen during the study? After chest tubes are removed, a trained medical trainee will use a small ultrasound device to check the lungs at the bedside. The patient will also have a chest X-ray, which is the usual test. The results from the ultrasound will be compared to the chest X-ray and reviewed by expert doctors.
What is the goal of the study? The goal is to see if it is possible to train medical trainees to use lung ultrasound safely and accurately in real hospital settings. The results will help plan a larger study in the future.
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 of using a chest X-ray.
Collapsed lungs can happen after chest tubes are removed, which is a common step after heart surgery. While chest X-rays are usually used to check for this, they can sometimes miss cases or take time to complete. Lung ultrasound is a fast, safe, and radiation-free tool that can be done right at the bedside.
In this study, medical trainees-such as anesthesia residents, critical care fellows, or internal medicine residents-will receive focused training on how to use lung ultrasound. After training, they will perform lung ultrasound exams on patients within two hours after chest tube removal. These results will be compared to chest X-rays, and also reviewed by expert doctors who are blinded to the trainee's findings.
The study will take place at three large hospitals in Ontario, Canada. It will include about 120 patients in total. The study team will look at how well trainees follow the protocol, how accurate their ultrasound readings are, and how patients feel about having ultrasound done at the bedside.
This study does not involve any new treatments or medications. The purpose is to see if lung ultrasound can be safely and effectively performed by trainees, and whether a larger study should be done in the future to confirm its benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Cardiac Surgery Patients Undergoing Chest Tube Removal | This cohort includes adult patients who have undergone cardiac surgery and are scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit. Each participant will undergo a lung ultrasound performed by a trained medical trainee and a standard chest X-ray to assess for pneumothorax. No interventions are assigned; this is an observational comparison of two diagnostic modalities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate Across Sites | Recruitment feasibility will be measured by the number of participants enrolled per site per month. The target is at least 2 patients per site per month across three participating centers. Unit of Measure: Participants per site per month | Up to 12 months after study start |
| Protocol Adherence to Lung Ultrasound Procedures | Percentage of enrolled participants with complete protocol adherence, defined as having both lung ultrasound and chest X-ray performed and documented as per protocol, including all required images and forms. Unit of Measure: Percentage. | Up to 12 months after study start |
| Participant Attrition Rate | Percentage of enrolled participants who withdraw or are lost to follow-up before completion of study procedures. The study aims to maintain an attrition rate below 10%. Unit of Measure: Percentage. | Up to 12 months after study start |
| Inter-Rater Agreement Between Novice and Expert Ultrasound Reviewers | Inter-rater reliability for lung ultrasound interpretation between novice trainees and expert reviewers, measured using kappa statistics. The target agreement is a kappa ≥ 0.8. Unit of Measure: Kappa statistic. | Up to 12 months after study start |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Agreement Between Novice-Performed Lung Ultrasound and Chest X-Ray for Pneumothorax Detection | This outcome compares the diagnostic accuracy of lung ultrasound performed by trained medical trainees to standard chest X-ray for pneumothorax detection following chest tube removal. Agreement will be assessed using kappa statistics. Expert reviewers will independently evaluate LUS images while radiologists will interpret CXR images, both blinded to each other's findings. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Sensitivity and Specificity of Lung Ultrasound vs. Chest X-Ray | Sensitivity and specificity of novice-performed lung ultrasound will be calculated for pneumothorax detection, using expert-reviewed chest X-ray as the clinical standard. | Within 2 hours of chest tube removal |
| Image Quality Scores of Trainee-Performed Lung Ultrasound |
Inclusion Criteria:
Exclusion Criteria:
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This study will enroll adult patients (18 years or older) who have undergone cardiac surgery and are scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU). Participants will be recruited from three high-volume cardiac centers in Ontario, Canada: Sunnybrook Health Sciences Centre, Toronto General Hospital, and London Health Sciences Centre. Patients must be able to safely undergo both lung ultrasound and chest X-ray after chest tube removal. Individuals with severe lung disease or who are mechanically ventilated at the time of eligibility screening will be excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacobo Moreno Garijo, MD, PhD | Contact | 416-480-4864 | jacobo.morenogarijo@sunnybrook.ca | |
| Lilia Kaustov, MSc, PhD | Contact | 416-480-6100 | 89607 | lilia.kaustov@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Angela Jerath, MD | Sunnybrook Health Sciences Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21615445 | Background | McAlinden C, Khadka J, Pesudovs K. Statistical methods for conducting agreement (comparison of clinical tests) and precision (repeatability or reproducibility) studies in optometry and ophthalmology. Ophthalmic Physiol Opt. 2011 Jul;31(4):330-8. doi: 10.1111/j.1475-1313.2011.00851.x. Epub 2011 May 26. | |
| 10501650 | Background |
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At this time, no decision has been made regarding the sharing of individual participant data (IPD). The primary aim of this study is to assess feasibility and diagnostic accuracy in a small, multicenter pilot cohort. If future analysis supports broader data sharing and aligns with institutional ethics and privacy policies, a data-sharing plan may be developed for the larger, definitive trial.
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to 2 hours after chest tube removal on Day 0 |
| Time to Diagnosis: Lung Ultrasound vs. Chest X-Ray | Compare the time from chest tube removal to pneumothorax diagnosis using lung ultrasound versus chest X-ray. Time will be measured in minutes from tube removal to the documented result of each imaging modality. | Up to 2 hours after chest tube removal on Day 0 |
| Patient-Reported Experience With Lung Ultrasound | Assess patient-reported comfort, acceptability, and imaging preference using a short questionnaire with Likert-scale responses following lung ultrasound. | Immediately after lung ultrasound on Day 0 |
| Adverse Events Related to Missed Pneumothorax | Monitor for complications associated with missed or delayed pneumothorax diagnosis, including respiratory failure, chest tube reinsertion, ICU readmission, or in-hospital mortality. | From chest tube removal through hospital discharge (up to 14 days, based on the expected max stay) |
Expert reviewers will assess image quality using a 3-point scale (inadequate, adequate, optimal) for each LUS exam performed by trainees. The proportion of adequate or better images will be reported. |
| Immediately following each lung ultrasound (same day as chest tube removal) |
| Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204. |
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