Fingertip Pulse Oximeter Clinical Test

SPO2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605955
• Other study ID #: AndonHealth8
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: May 23, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Andon Health Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 32 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• SPO2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Andon Health Co., Ltd