Smartphone Application for Automated Measurement of Capillary Refill Time (CRT)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Capillary Refill Time, Peripheral Tissue Perfusion. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This prospective, monocenter observational study aims to validate a smartphone application (CRTApp) that automatically measures capillary refill time (CRT) from a short video of a standardized finger compression. Sixty adult intensive care unit (ICU) patients will undergo a CRT measurement recorded with a professional Android smartphone. Clinical CRT will be determined from the video by three blinded observers (reference = median of the three measurements). The application will analyze the same video locally to provide an automated CRT measurement. Agreement between automated and clinical reference CRT will be assessed, and predefined subgroup analyses will explore performance across skin tone, ambient lighting, smartphone characteristics, and severity of peripheral hypoperfusion.
Подробное описание
Capillary refill time (CRT) is a bedside indicator of peripheral perfusion, but visual assessment is prone to inter-observer variability. In this study, CRT is measured using a standardized method (10-second finger compression with a glass slide). A video of the fingertip is captured without audio; framing is strictly limited to the fingers. Files are pseudonymized at acquisition. Videos are transferred via USB to an AP-HP workstation and stored on an AP-HP server; no cloud or messaging is used, and videos are deleted from the smartphone after import. Automated CRT is computed locally from the video by CRTApp without network transmission and without retaining the video. Statistical analyses will include intraclass correlation coefficient and Bland-Altman analysis for agreement. Secondary analyses will evaluate agreement stratified by skin tone (Monk scale / ITA), ambient lighting (lux), smartphone characteristics, and severity of peripheral hypoperfusion.
Первичные конечные точки
- Agreement Between Automated and Clinical Capillary Refill Time Measurement [Срок оценки: At inclusion (single assessment)]
Вторичные конечные точки (5)
- Inter-Observer Variability of Clinical Capillary Refill Time Measurement [Срок оценки: Inter-observer variability of clinically measured capillary refill time assessed by three independent observers, expressed as the coefficient of variation.]
- Agreement Stratified by Skin Tone [Срок оценки: At inclusion (single assessment)]
- Agreement Stratified by Ambient Lighting Conditions [Срок оценки: Intraclass correlation coefficient between automated and clinical capillary refill time measurements stratified according to ambient light intensity measured in lux.]
- Agreement Stratified by Smartphone Model Characteristics [Срок оценки: Intraclass correlation coefficient between automated and clinical capillary refill time measurements stratified by smartphone type (iOS or Android) and camera resolution.]
- Agreement Stratified by Severity of Peripheral Hypoperfusion [Срок оценки: Intraclass correlation coefficient between automated and clinical capillary refill time measurements stratified by clinical capillary refill time (< 3 seconds versus ≥ 3 seconds).]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Adult patients hospitalized in an intensive care unit
- Clinical indication for capillary refill time assessment (hemodynamic monitoring, suspected peripheral hypoperfusion, or therapeutic evaluation)
- No objection from the patient or legal representative
Критерии исключения
- Skin lesions at the measurement site
- Known severe peripheral vascular disease
- Finger amputation
- Presence of distinctive skin marks on fingers (tattoos, significant scars, or prominent moles) that may interfere with measurement or increase the risk of patient re-identification
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- CHU Bicêtre — Le Kremlin-Bicêtre
Идентификаторы
NCT: NCT07473869 · APHP251601