Clinical trial NCT06022081: Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pneumothorax
Keywords: Pneumothorax
Lung Ultrasound
Chest X-Ray
Trauma patients
Cardiac Surgery
Chest Drain Removal
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group study where the focus is on evaluating the diagnostic accuracy of both CXR and LUS for PNX detection post-tube removal in cardiac surgery and trauma patients. The study aims to compare the results of both modalities within the same group of participants to assess their performance in detecting PNX.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Diagnosing and promptly treating pneumothorax (PNX) is critical, as it is associated with increased morbidity, mortality, and hospital stay for patients. Following cardiac surgery, timely identification of PNX is particularly vital due to patients' reduced cardiopulmonary reserve, which can rapidly lead to life-threatening situations. While computed tomography (CT) is highly accurate in diagnosing PNX, its routine use for screening is impractical due to high radiation exposure, cost, and limited availability. Currently, the standard method for PNX detection is chest X-ray (CXR), but its reliability is suboptimal, resulting in potential misdiagnoses and delays in patient care.

An alternate method for detecting PNX is using lung ultrasound (LUS). LUS is safe, portable compared to CXR, has the potential for faster results and higher accuracy relative to CXR. LUS can also be carried out by appropriate trained nurses and medical trainees, instead of requiring an expert radiographer. This prospective, single-center, observational, cross-sectional, cohort, feasibility pilot trial assesses trainee-performed bedside lung ultrasound (LUS) for detecting PNX and testing feasibility for a multicenter observational prospective study.

The investigators will also compare PNX detection using LUS by novices compared to experts, interrater reliability and the time required from chest/mediastinal tube removal to diagnostic report for LUS. All participants will undergo assessment for PNX using both LUS and CXR completed independently (by study-trained critical care nurse/surgical trainee or an expert radiologist, respectively) and results will be compared between the two modalities.

The successful implementation of LUS could lead to streamlined patient care and improved outcomes for cardiac surgery and trauma patients.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months (full pilot trial)
measure: Adherence to LUS Scan Protocol
timeFrame: 12 months (full pilot trial)
measure: Feasibility of Accurate LUS Data Collection for Comparison with Chest X-rays
timeFrame: 12 months (full pilot trial)
Secondary outcomes:
measure: Compare novice-performed LUS with CXR reports performed by experienced radiologists.
timeFrame: 12 months (full pilot trial)
measure: Diagnostic accuracy of LUS vs CXR
timeFrame: 12 months (full pilot trial)
measure: Diagnostic Sensitivity of CXR vs LUS
timeFrame: 12 months (full pilot trial)
measure: Interrater reliability
timeFrame: 12 months (full pilot trial)
measure: Time Required
timeFrame: 12 months (full pilot trial)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Jacobo Moreno Garijo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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