CompletedNot Applicable

AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring

United States72 participantsStarted 2024-01-31

Plain-language summary

The purpose of this research study is to evaluate the effectiveness of the AION BIOSYTEMS, INC. tempshield ("Shield") temperature monitoring device and platform in detecting body temperature for children 2-4 years old. The ED Research team will be deploying this device on all qualified patients who are awaiting inpatient admission from the emergency department and who have consented to participating in the study. Patients will be asked to keep the device on for a maximum of 7 hours during their stay in the emergency department. There is a potential clinical benefit that fevers will be detected earlier in subjects wearing the AION BIOSTYEMS, INC. tempshield. It is hoped that information gained from the study will help assist clinical care workflow and the treatment of future patients.

Who can participate

Age range1 Year – 4 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female patients between ages 1 years - 4 years of age * Confirmed oral temperature of \>=99.5 F for febrile participants * Willing and likely (based on the investigator's judgement) to comply with all study requirements Exclusion Criteria: * Participants who are allergic to silicone * Adolescents with sensory issues who may find it difficult to have a wearable device on their chest. * Participants presenting an anatomical limitation that would prevent the use of the wearable device

What they're measuring

Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer

Timeframe: 24 Hours

Trial details

NCT IDNCT07145541

SponsorAION Biosystems

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-10

Results submitted2025-10-02