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Percussion Device (PD) for Detection of Pneumothorax

Primary Purpose

Pneumothorax

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Percussion Device (PD)
Ultrasound (US)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumothorax focused on measuring pneumothorax, chest tube removal, percussion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PD arm

US arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inter-rater reliability
The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.
Adverse Events
Any adverse event associated with the PD or ultrasound or CXR.
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.

Full Information

First Posted
September 2, 2017
Last Updated
August 16, 2021
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03272815
Brief Title
Percussion Device (PD) for Detection of Pneumothorax
Official Title
Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Device requires further modification
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
pneumothorax, chest tube removal, percussion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective clinical feasibility cohort study.
Masking
Outcomes Assessor
Masking Description
Radiologists are unaware of the intervention or the nature of the study.
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD arm
Arm Type
Experimental
Arm Description
Patients undergoing assessment of the chest with the percussion device (PD).
Arm Title
US arm
Arm Type
Active Comparator
Arm Description
Patients undergoing assessment of the chest with the ultrasound (US).
Intervention Type
Device
Intervention Name(s)
Percussion Device (PD)
Intervention Description
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
Intervention Name(s)
Ultrasound (US)
Intervention Description
The SonoSite hand help portable ultrasound device.
Primary Outcome Measure Information:
Title
Performance metrics
Description
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 Outcome Measure Information:
Title
Inter-rater reliability
Description
The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR.
Time Frame
2 years
Title
Adverse Events
Description
Any adverse event associated with the PD or ultrasound or CXR.
Time Frame
2 years
Title
Marginal Costs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Malthaner, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Percussion Device (PD) for Detection of Pneumothorax

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