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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD arm | Experimental | Patients undergoing assessment of the chest with the percussion device (PD). |
|
| US arm | Active Comparator | Patients undergoing assessment of the chest with the ultrasound (US). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percussion Device (PD) | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Malthaner, MD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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A prospective clinical feasibility cohort study.
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Radiologists are unaware of the intervention or the nature of the study.
| Ultrasound (US) | Device | The SonoSite hand help portable ultrasound device. |
|
| 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 |