Respiration From Pleth Validation

Conditions

• Respiratory Rate Monitoring

Eligibility Criteria

Sex

ALL

Age

4 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Physiological Monitoring with SpO₂ Sensors and Capnography — DEVICE
  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 capnography waveforms. All monitoring is observational, and no device output is used for clinical decision-making.

Study Details

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.

Key Dates

Start date

Feb 6, 2026

Status verified

Feb 2026

Primary completion

May 25, 2026

Completion

May 25, 2026

Study Design

Enrollment

113 participants (estimated)

Arms

• Arm: 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.
• Arm: 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).

Primary Outcome Measure

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

Central Contacts

• Nero Evero, Clinical Study Manager, MS
  +1 720-201-7689
  [email protected]

Locations (1)

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