N/A
Completed N=72
AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring
Source: ClinicalTrials.gov NCT07145541 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer — 0.0 degrees Celsius
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Temperature Reported by the AION Tempshield Compared to the Welch Allyn 901053 Electronic Thermometer |
0.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT07145541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.