Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Masimo

Status: Completed

Conditions: Fever

Treatments: Device: Masimo INVSENSOR00063

Study type: Interventional

Funder types: Industry

Identifiers

NCT05787782

KOEI0004

Details and patient eligibility

About

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Full description

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397).

Enrollment: 60 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant age ≥ 1 year
• Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
• English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Masimo INVSENSOR00063

Experimental group

Description:

All subjects are enrolled into this arm and will have temperature measurements obtained.

Treatment:

Device: Masimo INVSENSOR00063