Calibration and Validation of the Masimo Temperature Device in Febrile Patients

NCT05674344 | Completed Results FDA Device

• 1 other identifier: CHOC0008
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to standard methods of taking temperature such as inserting a probe under the tongue or using a forehead thermometer. Participants will be asked to sit still while rounds of measurements are taken using the Masimo temperature device and the reference temperature device. Researchers will compare the measurements taken with the Masimo device with the measurements taken with the reference device.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• Accuracy of Masimo RAD-GT Temperature Measurments

  The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (degrees Celsius).

  15-30 Minutes

Study Arms (1)

Masimo noninvasive temperature device

EXPERIMENTAL

All subjects who qualify for the trial and participate in data collection will have temperature taken using the Masimo noninvasive temperature device and the reference temperature device.

Device: Masimo Temperature device

Interventions

Masimo Temperature device DEVICE

Non-invasive temperature device

Masimo noninvasive temperature device

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age ≥ 1year old
• Febrile at time of enrollment: ≥ 99.5oF/37.5oC for patients ages 1-5 years; ≥ 100.4oF/38oC for patients older than 5 years old.
• English- or Spanish-speaking patient or parent/LAR

You may not qualify if:

• Patients deemed not suitable for the study at the discretion of the investigator
• Patients who are rated as a 1 or 2 Emergency Severity Index

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Site 1

Orange, California, 92630, United States

Location

Related Links

• NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
• NCT05779397, Clinical Performance of Masimo Rad-GT

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

(949) 297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: December 1, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-06

Locations

US (1)