Percussion Device (PD) for Detection of Pneumothorax

NCT03272815 | Terminated

• 1 other identifier: 109205
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax

Keywords

pneumothorax; chest tube removal; percussion

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Inter-rater reliability

  2 years

• Adverse Events

  2 years

• Marginal Costs

  2 years

Study Arms (2)

PD arm

EXPERIMENTAL

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

Device: Percussion Device (PD)

US arm

ACTIVE COMPARATOR

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

Device: Ultrasound (US)

Interventions

Percussion Device (PD) 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.

PD arm

Ultrasound (US) DEVICE

The SonoSite hand help portable ultrasound device.

US arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at London Health Sciences Centre (LHSC), London, Ontario.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Pneumothorax

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Richard Malthaner, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiologists are unaware of the intervention or the nature of the study.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Surgeon

Model Details: A prospective clinical feasibility cohort study.

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 6, 2017
• Study Start: May 10, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)