Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

Anemia Clinical Trial

Official title:

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610269
• Other study ID #: TORR0003
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 16, 2018

Study information

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

Clinical Trial Summary

The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 16, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Subject has given written informed consent to participate in the study

Exclusion Criteria:

• (*) Pregnant or positive human chorionic gonadotropin (hCG) test

• (*) Any severe coagulopathy, chronic bleeding disorders (i.e., hemophilia) or recent thrombolysis

• (*) Hemoglobinopathies and synthesis disorders (i.e., sickle cell, thalassemias, etc.)

• (*) Subjects who are currently taking anticoagulant medication

• (*) Subjects with allergies to lidocaine, Pain Ease, latex, adhesives, or plastic

• (*) 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 psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.

• (*) 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.

• (*) Subjects with elevated blood pressure, skin or wrist abnormalities that may interfere with an arterial blood draw as determined by investigator or research medical staff.

• (*) Subjects who intend on participating in heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw

• Subjects deemed not suitable for the study at the discretion of the investigator or research medical staff

Note: (*) May be self-reported by subject

Related Conditions & MeSH terms

• Anemia

Intervention

Device:
• INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)

Locations

Country	Name	City	State
United States	Torrance Clinical Research	Lomita	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 Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation	Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.	Up to 2 hours per subject