Respiration From Pleth Validation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Adult Inpatients
Adult participants (aged 18 years and older) will undergo noninvasive physiological monitoring using adult-appropriate Philips SpO₂ sensors during a single study visit. Each participant completes two separate 20-minute recording cycles. The first cycle includes simultaneous monitoring with the M1191T adult finger sensor (>50 kg) and the nasal alar sensor (989803205391; ≥15 kg). The second cycle includes the M1191T adult finger sensor and the M1194A ear sensor (>40 kg). During both cycles, capnography is recorded concurrently using the LoFlo Sidestream etCO₂ sensor (M2741A) connected to an adult oral/nasal cannula (989803206671). All monitoring is observational, and device outputs are not used for clinical decision-making.
干预措施: Physiological Monitoring with SpO₂ Sensors and Capnography (Device)
Pediatric Inpatients
Pediatric participants aged 4-17 years receiving physiological monitoring with pediatric-appropriate Philips SpO₂ sensors (M1192A finger glove for 15-50 kg; nasal alar sensors for ≥15 kg; ear sensor M1194A for >40 kg when age ≥12 years). Participants complete one or two 20-minute recording cycles depending on age/weight per protocol. Capnography is collected using the LoFlo Sidestream etCO₂ sensor with pediatric oral/nasal cannula (989803206681).
干预措施: Physiological Monitoring with SpO₂ Sensors and Capnography (Device)
结局指标
主要结局
Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring
时间窗: During the 20-minute continuous monitoring period for the finger sensor.
Accuracy Root Mean Square (ARMS) between respiratory rate derived from plethysmography using Philips FAST Pulse Oximetry technology and respiratory rate derived from clinician-annotated capnography waveforms. Metric: ARMS (breaths per minute). Pass/Fail Criterion: ARMS ≤ 3 BPM per population (adult, pediatric).
次要结局
- Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)(20-minute continuous monitoring period.)
- Mean Bias - All Sensor Types (Continuous Monitoring)(20-minute continuous monitoring.)
- Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)(20-minute continuous monitoring.)
- Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)(0-5 minutes after sensor connection (spot-check period).)
- Mean Bias - Finger Sensor (Spot-Check Monitoring)(0-5 minutes after sensor connection (spot-check period).)
- Precision - Finger Sensor (Spot-Check Monitoring)(0-5 minutes after sensor connection (spot-check period).)
- Time to First Valid Pleth-Derived Respiratory Rate Value(Measured during the initial minutes of recording for each finger-sensor cycle.)
- Patient Acceptability and Satisfaction (Adult CO₂ Cannula Survey)(Immediately after monitoring procedure.)