Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

NCT06460246 | Completed

• 1 other identifier: Pro00077383
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

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.

  1-4 hours

Study Arms (1)

Pulse Oximeter

EXPERIMENTAL

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

Pulse Oximeter DEVICE

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.

Pulse Oximeter

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acurable Ltd.: lead

Study Sites (1)

Vital Signs Research Group, L.L.C.

San Francisco, California, 94107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 25, 2024
• Primary Completion: June 27, 2024
• Study Completion: July 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)