Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Primary Endpoint
- Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population
Study Overview
Brief Summary
This prospective, single-arm, self-controlled validation study aims to evaluate the accuracy and safety of the Spirometry Test System (STS) handheld device in measuring pulmonary parameters in pediatric subjects aged 7-17 years.
Each participant will undergo pulmonary function testing using both conventional laboratory methods (spirometry and body plethysmography) and the STS device in randomized order. Agreement between methods, repeatability of measurements, and device safety will be assessed. The study will be conducted at Children's National Hospital, Washington, USA
Detailed Description
Pulmonary function testing (PFT) is essential for diagnosing and monitoring respiratory diseases in pediatric patients. Conventional PFT requires body plethysmography and laboratory spirometry, which can be time-consuming and challenging for children.
The Spirometry Test System (STS) is a portable handheld device capable of measuring spirometry parameters and lung volumes without the need for a plethysmograph chamber. The STS device is FDA cleared for use in adult patients (FDA 510(k) K240293). However, its performance has not yet been validated in the pediatric population.
This study aims to evaluate the accuracy and safety of the STS device in pediatric subjects aged 7-17 years.
Pediatric patients referred for clinically required pulmonary function testing will perform lung function testing using both conventional laboratory methods (spirometry and body plethysmography) and the STS device. The testing order will be randomized to minimize order bias. Each test will be performed by a different technician, and technicians will remain blinded to the results of the alternate testing method.
The primary objective is to evaluate agreement between STS measurements and conventional pulmonary function testing using Bland-Altman analysis. Secondary objectives include assessment of repeatability and safety evaluation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric subjects aged 7-17 years able to cooperate with testing
- •Referred for clinically required pulmonary function testing
- •Informed consent obtained from legal guardian
Exclusion Criteria
- •Inability to perform lung function testing
- •Inability or unwillingness to provide consent
- •Presence of tracheostomy
- •Pulmonary edema
Arms & Interventions
STS and Conventional Pulmonary Function Testing
Participants will undergo pulmonary function testing using both the STS handheld device and conventional laboratory spirometry and body plethysmography in randomized order.
Intervention: Spirometry Test System (STS) (Device)
Outcomes
Primary Outcomes
Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population
Time Frame: During study visit (single session)
Agreement between measurements obtained using the STS device and conventional pulmonary function tests for spirometry parameters, lung volumes, airway resistance, and lung compliance using Bland-Altman analysis.
Secondary Outcomes
- Repeatability of STS Measurements in pediatric population(During study visit)