Percussion Device (PD) for Detection of Pneumothorax

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.

Full Title of Study: “Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 1, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: PD arm
    • Patients undergoing assessment of the chest with the percussion device (PD).
  • Active Comparator: US arm
    • Patients undergoing assessment of the chest with the ultrasound (US).

Clinical Trial Outcome Measures

Primary Measures

  • Performance metrics
    • Time Frame: 2 years
    • 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.

Secondary Measures

  • Inter-rater reliability
    • Time Frame: 2 years
    • The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.
  • Adverse Events
    • Time Frame: 2 years
    • Any adverse event associated with the PD or ultrasound or CXR.
  • Marginal Costs
    • Time Frame: 2 years
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard Malthaner, Thoracic Surgeon – Lawson Health Research Institute
  • Overall Official(s)
    • Richard Malthaner, MD, Principal Investigator, Lawson Health Research Institute

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