Validation of the STS Device for Pulmonary Function Test in Pediatric Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirometry Test System (STS).
- Who it may be relevant to
- Registry conditions: Pulmonary Function Testing. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population
Overview
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.
The first 10 enrolled subjects will serve as an initial training set and will not be included in the final analysis. Interim analyses will be performed periodically throughout the study to ensure data quality and safety oversight.
The study involves a single visit and no follow-up assessments.
Interventions
- Device Spirometry Test System (STS)
A handheld device used to measure spirometry parameters and lung volumes including FEV1, FVC, TLC, RV, TGV, airway resistance and respiratory compliance.
Primary outcome measures
- Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population [Time frame: During study visit (single session)]
Secondary outcome measures (1)
- Repeatability of STS Measurements in pediatric population [Time frame: During study visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07430709 · STS003