Pneumothorax Clinical Trial
— LUSvsCXROfficial title:
Comparative Evaluation of Novice-Performed Lung Ultrasound vs. Chest X-Ray for Pneumothorax Detection Post-Chest Tube Removal in Cardiac Surgery and Trauma Patients
NCT number | NCT06022081 |
Other study ID # | 5854 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 27, 2023 |
Est. completion date | September 2025 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old. - Cardiac and trauma patients who have had a chest/mediastinal tube removed within the past two hours in the CVICU, trauma bay, or ward. Exclusion Criteria: - Patients who had a PNX prior to mediastinal chest tube removal that required intervention. - Patients on mechanical ventilation. - Patients with subcutaneous emphysema due to impaired pleural line visualization. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | The total number of participants recruited during the pilot trial. Target: 60 participants. | 12 months (full pilot trial) | |
Primary | Adherence to LUS Scan Protocol | The proportion of participants who receive the LUS scans as per the trial protocol. This will be assessed by checking the frequency of LUS scans conducted for each participant against the planned frequency in the protocol. Measurement Tool: Frequency count of LUS scans against planned protocol scans. | 12 months (full pilot trial) | |
Primary | Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays | Evaluate the feasibility of obtaining accurate LUS data suitable for comparison against Chest X-rays. The accuracy of LUS scans will be determined by the clarity and consistency of recorded data points. For the purpose of this study, 'accuracy' will be defined by a set of criteria based on sonographic signs of pneumothorax that include: absence of lung sliding, absence of B lines, presence of lung point, and absence of lung pulse. The primary outcome will be the proportion of LUS scans that meet this accuracy threshold. Measurement Tool: Qualitative assessment criteria tailored for this study. LUS scans will be evaluated based on clarity, consistency of recorded data points, and adherence to the sonographic signs of pneumothorax as listed above. The results from LUS will then be prepared for comparison against Chest X-ray findings in subsequent analyses. | 12 months (full pilot trial) | |
Secondary | Compare novice-performed LUS with CXR reports performed by experienced radiologists. | The results of the assessments will be analyzed to determine the sensitivity, specificity, positive predictive value, and negative predictive value of pneumothorax detection by novices compared to experts. | 12 months (full pilot trial) | |
Secondary | Diagnostic accuracy of LUS vs CXR | Assess diagnostic accuracy and sensitivity of PNX detection by CXR and LUS (80% interrater reliability with the results when LUS is adjudicated by an expert for detecting PNX post-chest/mediastinal tube removal). | 12 months (full pilot trial) | |
Secondary | Diagnostic Sensitivity of CXR vs LUS | Assess diagnostic sensitivity of PNX detection by CXR and LUS (80% interrater reliability with the results when LUS is adjudicated by an expert for detecting PNX post-chest/mediastinal tube removal). | 12 months (full pilot trial) | |
Secondary | Interrater reliability | Assess the interrater reliability of novice and expert sonographers. | 12 months (full pilot trial) | |
Secondary | Time Required | Assess the time required from chest/mediastinal tube removal to diagnostic report for LUS vs CXR. | 12 months (full pilot trial) |
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