Идёт набор NCT07449715

Respiration From Pleth Validation

— Наблюдательное Respiratory Rate Monitoring

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: В протоколе указаны: Physiological Monitoring with SpO₂ Sensors and Capnography.
Кому может быть актуально: Состояния в реестре: Respiratory Rate Monitoring. Базовые параметры: от 4 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: США, Великобритания
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 observational clinical investigation evaluates the performance of respiratory rate derived from the plethysmography waveform (Respiration from Pleth, RfP) using Philips FAST Pulse Oximetry technology. Adult and pediatric inpatients will undergo noninvasive monitoring using age- and weight-appropriate SpO₂ sensors and capnography, with capnography serving as the reference standard. The study assesses accuracy, mean bias, precision, and time to first valid respiratory-rate value across continuous and spot-check conditions. No device outputs are used for clinical decision-making, and all procedures occur during a single study visit.

Подробное описание

Respiratory rate is a key clinical vital sign and an early indicator of patient deterioration, but traditional manual counting is often inaccurate and inconsistently performed. Prior research has demonstrated that respiratory rate can be derived from the plethysmography waveform used for SpO₂ monitoring. Philips has developed enhancements to its FAST Pulse Oximetry technology to derive respiratory rate from plethysmography (Respiration from Pleth, RfP). This clinical investigation is designed to validate the accuracy and performance of the RfP algorithm by comparing pleth-derived respiratory rate with respiratory rate obtained from clinician-annotated capnography waveforms.

This is a multi-center, prospective, non-randomized, non-blinded observational study enrolling adult and pediatric inpatients who are spontaneously breathing room air and undergoing routine spot-check vital signs. Each participant completes one study visit. Age- and weight-appropriate Philips SpO₂ sensors (finger, nasal alar, ear) are placed according to the sensor Instructions for Use, and capnography is collected using the LoFlo Sidestream etCO₂ sensor with adult or pediatric oral/nasal cannulas. For each applicable sensor type, a 20-minute plethysmography and capnography recording is collected. A spot-check analysis window covering the first 5 minutes of the finger-sensor recording is also evaluated. Manual respiratory rate is recorded once during this period.

Waveform data are annotated by clinicians blinded to other signals to identify normal breathing, exclude artifacts, and determine reference respiratory rate values. Respiratory rate accuracy is evaluated using Accuracy Root Mean Square (ARMS), mean bias, and precision. Predefined performance criteria specify ARMS ≤ 3 breaths per minute and mean bias between -1 and +1 BPM for each population. The investigation also evaluates time to first valid pleth-derived respiratory-rate value, as well as adult participant acceptability of the CO₂ cannula. Data collected during the study do not influence patient care, and the investigational respiratory-rate algorithm is not displayed on the monitoring equipment during data acquisition.

Вмешательства

Устройство Physiological Monitoring with SpO₂ Sensors and Capnography
Participants will undergo noninvasive physiological monitoring with commercially available Philips SpO₂ sensors (adult finger sensor M1191T; pediatric finger glove M1192A; nasal alar sensors 989803205391; adult/pediatric ear sensor M1194A) connected to Philips MP5 or PM6300 patient monitors configured with standard FAST Pulse Oximetry technology. A LoFlo Sidestream etCO₂ sensor (M2741A) with an adult or pediatric oral/nasal cannula (989803206671 or 989803206681) will be used to collect reference

Первичные конечные точки

Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring [Срок оценки: During the 20-minute continuous monitoring period for the finger sensor.]

Вторичные конечные точки (8)

Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring) [Срок оценки: 20-minute continuous monitoring period.]
Mean Bias - All Sensor Types (Continuous Monitoring) [Срок оценки: 20-minute continuous monitoring.]
Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring) [Срок оценки: 20-minute continuous monitoring.]
Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring) [Срок оценки: 0-5 minutes after sensor connection (spot-check period).]
Mean Bias - Finger Sensor (Spot-Check Monitoring) [Срок оценки: 0-5 minutes after sensor connection (spot-check period).]
Precision - Finger Sensor (Spot-Check Monitoring) [Срок оценки: 0-5 minutes after sensor connection (spot-check period).]
Time to First Valid Pleth-Derived Respiratory Rate Value [Срок оценки: Measured during the initial minutes of recording for each finger-sensor cycle.]
Patient Acceptability and Satisfaction (Adult CO₂ Cannula Survey) [Срок оценки: Immediately after monitoring procedure.]

Критерии участия

Критерии включения

Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
UK Pediatric subjects:

Aged 16 years and older willing and able to understand and provide written informed consent
Aged 4-15 years and their legal guardians willing and able to understand and provide written informed consent/assent
US Pediatric Participants: aged 4 to 17 years and their parent/legal guardian are willing and able to understand and provide written informed assent/consent
Participant weight is within intended use of at least one SpO2 sensor under test as time of enrollment.

M1191T, adult participants > 50 kg
M1192A, pediatric participants 15-50 kg
Nasal Alar Sensor, adult and pediatric participants ≥ 15 kg
M1194A, adult and pediatric participants > 40 kg
Willing and able to wear study devices for the entirety of study procedures
Undergoing regular spot-check measurements as per the site's standard of care

Критерии исключения

Palliative patients
Patients with tremors, cardiac pacemakers, or known atrial fibrillation
Patients receiving oxygen supplementation at the time of study participation
Critically ill patients with severe physiological instability
Pregnant and/or lactating patients (self-reported)
Injury, wounds, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear)
Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors
Unwillingness or inability to remove colored nail polish or artificial nails from the application site
Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites
Nail fungus on application site
Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site

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

Здоровые добровольцы: Нет