NCT03272815

Percussion Device (PD) for Detection of Pneumothorax

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pneumothorax

Interventions

Type	Name	Description
DEVICE	Percussion Device (PD)	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.
DEVICE	Ultrasound (US)	The SonoSite hand help portable ultrasound device.

Timeline

• Start date: 2018-05-10
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2017-09-06
• Last updated: 2021-08-23

Locations

1 site across 1 country: Canada