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CompletedNCT06460246Updated Aug 23, 2024

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

An interventional study of Pulse Oximeter in Healthy, sponsored by Acurable Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Acurable Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

Read the detailed description

This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin saturation.

02

Conditions studied

  • Healthy

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 12 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Acurable Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female, aged >= 18 and \< 50.
  • Subject in good general health with no evidence of any medical problems.
  • Subject is fluent in both written and spoken English.
  • Subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  • Subject is obese (BMI > 35).
  • Subject has a known history of heart disease, lung disease, kidney, or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • Subject has hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  • Subject has any other serious systemic illness.
  • Subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
  • Subject has a history of fainting or vasovagal response.
  • Subject has a history of sensitivity to local anesthesia.
  • Subject has a diagnosis of Raynaud's disease.
  • Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • Subject is pregnant, lactating, or trying to get pregnant.
  • Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Pulse Oximeter

    The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

    Device: Pulse Oximeter

Interventions

  • DevicePulse Oximeter

    The subjects will have a 22-gauge catheter inserted in the radial artery to measure the oxygen saturation of arterial blood and also wear pulse oximeters.

06

What researchers measure

Primary outcomes

  1. Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.

    Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.

    Time frame: 1-4 hours

07

Study locations

1 site
  • Vital Signs Research Group, L.L.C.
    San Francisco, California 94107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06460246
Lead sponsor
Acurable Ltd.
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jun 25, 2024
Primary completion
Jun 27, 2024
Completion
Jul 31, 2024
Last update
Aug 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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