Spot-Check Noninvasive Pulse CO-Oximeter Validation

Anemia Clinical Trial

Official title:

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782806
• Other study ID #: TORR0001
• Status: Completed
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: May 19, 2016

Study information

• Verified date: April 2019
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: May 19, 2016
• Est. primary completion date: May 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

Inclusion Criteria:

• Male or female

• Age: Greater than one month

• Weight: Greater than or equal to 3kg

• Any racial or ethnic group

• The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

• If an ICU patient, total hemoglobin of < 9 g/dL at time of screening.

Exclusion Criteria:

• Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.

• Subjects deemed not suitable for the study at the discretion of the investigator

• Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Related Conditions & MeSH terms

• Anemia

Intervention

Device:
• Masimo Rad-67 Pulse Oximeter
Noninvasive pulse oximeter

Locations

Country	Name	City	State
United States	Masimo Corporation	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of sensor	Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.	Up to 1 hr per subject