Percussion Device (PD) for Detection of Pneumothorax

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Pneumothorax

Interventions

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.

Ultrasound (US)DEVICE

The SonoSite hand help portable ultrasound device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Inter-rater reliability

The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.

Time frame: 2 years

Adverse Events

Any adverse event associated with the PD or ultrasound or CXR.

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.