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Percussion Device (PD) for Detection of Pneumothorax

L

Lawson Health Research Institute

Status

Terminated

Conditions

Pneumothorax

Treatments

Device: Ultrasound (US)
Device: Percussion Device (PD)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

13 participants in 2 patient groups

PD arm
Experimental group
Description:
Patients undergoing assessment of the chest with the percussion device (PD).
Treatment:
Device: Percussion Device (PD)
US arm
Active Comparator group
Description:
Patients undergoing assessment of the chest with the ultrasound (US).
Treatment:
Device: Ultrasound (US)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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