Performance Comparison Between Masimo W1™ and Apple Watch Series 8

Masimo

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: Masimo W1™ and Apple Watch Series 8

Study type

Interventional

Funder types

Industry

Identifiers

NCT05968079

MACL0003

Details and patient eligibility

About

This study is also designed to compare the performance of Masimo W1™ and Apple Watch Series 8 against FDA cleared hospital grade pulse oximetry technology under desaturation conditions.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is 18 to 55 years of age.
Subject is American Society Anesthesiologist status 1 (ASA I)
Subject has a BMI between 18 and 35.
Subject is able to read and communicate in English and understands the study and the risks involved.

Exclusion criteria

Subject is currently taking any medications which in the opinion of the principal investigator would not be suitable for participation in the study.
Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails that can interfere with study device's placement.
Participants with conditions or skin abnormalities at or around site of sensor placement that could affect the placement on the sensor or prevent monitoring of physiological parameters during the study, such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown.
Subject has participated in an investigational drug study within one month prior to the start of the study.
Subject has failed the Allen's Test to confirm patency of the collateral artery.
Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination.
Subject has a positive urine cotinine or drug test.
Subject has a reported allergy to Lidocaine.
Subject has clinically significant anemia or other hemoglobinopathy.
Subject has a room air saturation of less than 95% by pulse oximetry.
Subject has a clinically significant abnormal EKG.
Subject has a clinically significant abnormal pulmonary function test via spirometry.
Subject is intolerant to a breathing mask apparatus.
Subject has a COHb greater than 3%, or MetHb greater than 2% verified by laboratory co-oximeter.
Subject has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Subject is unwilling or unable to provide informed consent or comply with the study procedures.