Clincosm LogoSign in Get a demo

Percussion Device (PD) for Detection of Pneumothorax

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT03272815
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
17.7
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Percussion Device (PD)
  • Device: Ultrasound (US)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
A prospective clinical feasibility cohort study.A prospective clinical feasibility cohort study.
Masking:
Single (Outcomes Assessor)
Masking Description:
Radiologists are unaware of the intervention or the nature of the study.
Primary Purpose:
Diagnostic
Official Title:
Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery
Actual Study Start Date :
May 10, 2018
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: PD arm

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

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.
Active Comparator: US arm

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

Device: Ultrasound (US)
The SonoSite hand help portable ultrasound device.

Outcome Measures

Primary Outcome Measures

  1. Performance metrics [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 Outcome Measures

  1. Inter-rater reliability [2 years]

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

  2. Adverse Events [2 years]

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

  3. Marginal Costs [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre London Ontario Canada N6A 5W9

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Richard Malthaner, MD, Lawson Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Malthaner, Thoracic Surgeon, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT03272815
Other Study ID Numbers:
  • 109205
First Posted:
Sep 6, 2017
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard Malthaner, Thoracic Surgeon, Lawson Health Research Institute
pneumothorax
chest tube removal
percussion
Additional relevant MeSH terms:
Pneumothorax

Study Results

No Results Posted as of Aug 23, 2021