Percussion Device (PD) for Detection of Pneumothorax

Study Overview
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Brief Summary
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This study aims to examine the safety and efficacy of the Percussion Device in detecting a pneumothorax in patients that have undergone thoracic surgery.

Detailed Description
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A prospective, non-randomized clinical feasibility cohort study. The purpose of this feasibility study is to collect preliminary performance and safety information for the Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for study enrolment before their surgery in clinic. Following surgery and after the patient's chest tube has been removed, evaluation of the chest using the PD and ultrasound will be performed by two independent assessors (a nurse practitioner or resident on the Thoracic Surgery Team) prior to the post-removal CXR. Details of study procedure are details in section 2.8. The PD's performance metric will be compared against CXR results, which is considered the gold standard in diagnosing a pneumothorax.

Official Title
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Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery

Conditions
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Pneumothorax

Intervention / Treatment
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* Device: Percussion Device (PD)
* Device: Ultrasound (US)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at London Health Sciences Centre (LHSC), London, Ontario. Exclusion Criteria: Patients less than 18 years old Patients unable to consent Patients with known persistent pneumothorax prior to chest tube removal Patients who are pregnant Patients with severe chest wall deformity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective clinical feasibility cohort study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD arm<br>Patients undergoing assessment of the chest with the percussion device (PD). | Device: Percussion Device (PD)<br>* A laboratory prototype of the Percussion Device (PD) has been designed and built; laboratory data collection software, signal analysis and classification algorithms have been developed. It has been designed to detect a pneumothorax.<br>|
| Active Comparator: US arm<br>Patients undergoing assessment of the chest with the ultrasound (US). | Device: Ultrasound (US)<br>* The SonoSite hand help portable ultrasound device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance metrics | Performance metrics of the PD in detecting the presence of a pneumothorax following the removal of the last chest tube in patients that have undergone thoracic surgery compared to the CXR reported by a blinded radiologist unaware of the study. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability | The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR. | 2 years | 
| Adverse Events | Any adverse event associated with the PD or ultrasound or CXR. | 2 years | 
| Marginal Costs | Marginal costs differences between the surgeon performed PD and CXR will be based on an overall risk-benefit assessment that will take into account accuracy and costs of facilities as well as physician services. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumothorax, chest tube removal, percussion