Validation of the STS Device for Pulmonary Function Test in Pediatric Population

Официальное название

Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population [Срок оценки: During study visit (single session)]

Вторичные конечные точки (1)

• Repeatability of STS Measurements in pediatric population [Срок оценки: During study visit]

Критерии участия

Критерии включения

• Pediatric subjects aged 7-17 years able to cooperate with testing
• Referred for clinically required pulmonary function testing
• Informed consent obtained from legal guardian

Критерии исключения

• Inability to perform lung function testing
• Inability or unwillingness to provide consent
• Presence of tracheostomy
• Pulmonary edema

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07430709 · STS003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗