Fingertip Pulse Oximeter Clinical Test

Andon Health

Status: Completed

Conditions: SPO2

Study type: Observational

Funder types: Industry

Identifiers

NCT01605955

AndonHealth8

Details and patient eligibility

About

The purpose of this study is to validate the SpO2 accuracy of pulse oximeter equipment in comparison to "gold-standard" measurements of blood SaO2 by a CO-oximeter

Enrollment: 10 patients

Sex: All

Ages: 25 to 32 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects participate in the study on a voluntary basis
• All subjects should be in good health at the time of the study. Unless specified otherwise in the protocol, the following values could be applied: COHb<3 %, MetHb<2 %, ctHb>10 g/dl;
• Inclusion criteria should serve the purpose of the study

Exclusion criteria

• Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels, unless specific dyshaemoglobins are called for in the study protocol.
• Individuals subject to conditions that result in elevated levels of methaemoglobin, unless specific dyshaemoglobins are called for in the study protocol.
• Subjects who would be placed at undue medical risk associated with any procedures called for in the protocol (e.g. arterial cannulation or hypoxia).
• Age: young person and that of more than 50 years old.

Trial design

10 participants in 2 patient groups

Fingertip Pulse Oximeter

Description:

SPO2 measurement range: 70%-99%

CO-oximeter

Description:

SaO2 measurement range: 70%-99%