Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

August 21, 2024 updated by: Acurable Ltd.
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
Time Frame: 1-4 hours
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
1-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acurable Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00077383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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