Accuracy of Continuous SpO2 Measurement in Adults

Healthy Clinical Trial

— SPO2  

Official title:

SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01183338
• Other study ID #: SWI-US11-006
• Status: Withdrawn
• Phase: N/A
• First received: August 13, 2010
• Last updated: June 21, 2011

Study information

• Verified date: June 2011
• Source: Sotera Wireless, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

Description:

This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.

SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 15
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is at least 18 years of age.

• Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.

• Subject is willing and able to participate in the measurement period for up to two hours.

Exclusion Criteria:

• Subject has a carboxyhemoglobin level (COHb) =3%.

• Subject has a MetHb level =2%.

• Subject has a ctHb value =10g/dl.

• Subject is in another clinical study that may interfere with the results of this study.

• Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.

• Subject is deemed by the Investigator to be medically unsuitable for participation in this study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Clinimark Desaturation Laboratory	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Sotera Wireless, Inc.

Country where clinical trial is conducted

United States,