Active — Not RecruitingNot Applicable

Determination of SpO2 and PR Accuracy Specifications at Rest (71Ag_Vital-0031)

United States12 participantsStarted 2022-03-23

Plain-language summary

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Both male and female subjects who can give written informed consent * Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile * Meeting the demographic requirements Exclusion Criteria: * Pregnant women * Significant arrhythmia * Blood pressure above 150 systolic or 90 diastolic * Carboxyhemoglobin levels over 3% * Subjects whom the investigator consider ineligible for the study

What they're measuring

Root-mean-square (Rms) of device SpO2 measurement with room air stabilization is within +-2% [%SpO2] of reference co-oximeter SaO2 measurement at varying desaturation levels (70% to 100%)

Timeframe: 30 minutes

Root-mean-square (Rms) of device Pulse Rate measurement with room air stabilization is within +-3 [1/min] of reference ECG Pulse Rate measurement at heart rates (30 to 300 [1/min])

Timeframe: 30 minutes

Trial details

NCT IDNCT05297500

SponsorNihon Kohden

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-28

View on ClinicalTrials.gov More Hypoxia trials