AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring

Completed · Not applicable

Conditions studied: Fever, Sepsis

In brief

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.

Key facts

Study ID

NCT07145541

Run by

AION Biosystems

People needed

72

Starts

2024-01-31

Expected to finish

2024-10-10

Last updated by the study team

2025-11-19

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.