Percussion Device (PD) for Detection of Pneumothorax

NCT ID: NCT03272815

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-11-01

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.

Conditions

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Pneumothorax

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

A prospective clinical feasibility cohort study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Radiologists are unaware of the intervention or the nature of the study.

Study Groups

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PD arm

Patients undergoing assessment of the chest with the percussion device (PD).

Group Type EXPERIMENTAL

Percussion Device (PD)

Intervention Type 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.

US arm

Patients undergoing assessment of the chest with the ultrasound (US).

Group Type ACTIVE_COMPARATOR

Ultrasound (US)

Intervention Type DEVICE

The SonoSite hand help portable ultrasound device.

Interventions

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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.

Intervention Type DEVICE

Ultrasound (US)

The SonoSite hand help portable ultrasound device.

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Richard Malthaner

Thoracic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Malthaner, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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109205

Identifier Type: -

Identifier Source: org_study_id

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