Cardiac Surgery, Chest Tube Removal, Lung Ultrasound, Pneumothorax, Postoperative Complications (Cardiopulmonary)
Conditions
Keywords
Lung Ultrasound, Pneumothorax Detection, Chest Tube Removal, Cardiac Surgery, Point-of-Care Ultrasound, Postoperative Complication, Bedside Ultrasound, Novice Sonographer, Diagnostic Accuracy, Feasibility Study, Critical Care Ultrasound, Trainee-Performed Ultrasound, Chest X-Ray, Medical Education
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Sunnybrook Health Sciences Centre
Toronto General Hospital
London Health Sciences Centre
Jacobo Moreno Garijo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Undergoing cardiac surgery * Scheduled for chest and/or mediastinal chest tube removal in the cardiovascular intensive care unit (CVICU)
Exclusion criteria
* Severe chronic lung disease that may impair lung ultrasound interpretation, including: * Subcutaneous emphysema * COPD or emphysema with FEV₁ \< 50% predicted * Interstitial lung disease with FEV₁ \< 75% predicted * Documented history of pneumothorax prior to chest tube removal requiring intervention * Mechanical ventilation at the time of eligibility screening * Inability to undergo lung ultrasound or chest X-ray (e.g., due to hemodynamic instability or positioning limitations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Rater Agreement Between Novice and Expert Ultrasound Reviewers | Up to 12 months after study start | 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. |
| Participant Attrition Rate | Up to 12 months after study start | 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. |
| Recruitment Rate Across Sites | Up to 12 months after study start | 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 |
| Protocol Adherence to Lung Ultrasound Procedures | Up to 12 months after study start | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to Missed Pneumothorax | From chest tube removal through hospital discharge (up to 14 days, based on the expected max stay) | Monitor for complications associated with missed or delayed pneumothorax diagnosis, including respiratory failure, chest tube reinsertion, ICU readmission, or in-hospital mortality. |
| Diagnostic Agreement Between Novice-Performed Lung Ultrasound and Chest X-Ray for Pneumothorax Detection | Up to 2 hours after chest tube removal on Day 0 | 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. |
| Time to Diagnosis: Lung Ultrasound vs. Chest X-Ray | Up to 2 hours after chest tube removal on Day 0 | 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. |
| Patient-Reported Experience With Lung Ultrasound | Immediately after lung ultrasound on Day 0 | Assess patient-reported comfort, acceptability, and imaging preference using a short questionnaire with Likert-scale responses following lung ultrasound. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity and Specificity of Lung Ultrasound vs. Chest X-Ray | Within 2 hours of chest tube removal | Sensitivity and specificity of novice-performed lung ultrasound will be calculated for pneumothorax detection, using expert-reviewed chest X-ray as the clinical standard. |
| Image Quality Scores of Trainee-Performed Lung Ultrasound | Immediately following each lung ultrasound (same day as chest tube removal) | 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. |
Countries
Canada
Contacts
Primary ContactJacobo Moreno Garijo, MD, PhD
Backup ContactLilia Kaustov, MSc, PhD
Outcome results
None listed