Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Healthy Clinical Trial

Official title:

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460246
• Other study ID #: Pro00077383
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: Acurable Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: July 31, 2024
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hypoxia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acurable Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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