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RECRUITING
NCT07449715

Respiration From Pleth Validation

Sponsor: Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

4 Years - Any

Study Type

OBSERVATIONAL

Enrollment

113

Start Date

2026-02-06

Completion Date

2026-05-25

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DEVICE

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 capnography waveforms. All monitoring is observational, and no device output is used for clinical decision-making.

Locations (2)

Duke University Hospital

Durham, North Carolina, United States

Ysbyty Gwynedd

Bangor, Gwynedd, United Kingdom