Pneumothorax
Conditions
Keywords
pneumothorax, chest tube removal, percussion
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.
Interventions
DEVICEPercussion 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.
DEVICEUltrasound (US)
The SonoSite hand help portable ultrasound device.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Radiologists are unaware of the intervention or the nature of the study.
Intervention model description
A prospective clinical feasibility cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater reliability | 2 years | The secondary outcomes will include inter-rater reliability with the PD or ultrasound or CXR. |
| Adverse Events | 2 years | Any adverse event associated with the PD or ultrasound or CXR. |
| 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. |
Countries
Canada
Outcome results
None listed