AION BIOSYSTEMS, INC. Tempshield for Continuous Tempreature Monitoring

NCT ID: NCT07145541

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-10-10

Brief 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.

Detailed Description

A prospective, single site, interventional study assessing the effectiveness for use of the non-invasive wireless temperature monitoring device and platform in detecting body temperature of young children during 1st 7 hours of their stay in the emergency department for patients, between 2-4 years of age. The AION BIOSYSTEMS, INC. tempshield is a skin-applied, continuous temperature monitor. It is battery powered, communicates using Bluetooth LE to a smartphone, then to a clinician dashboard, and is designed to be worn continuously for up to 60 days. Its primary use is for patient monitoring in hospital or post-discharge from a healthcare facility. This study is designed as prospective, interventional study assessing the effectiveness of the AION BIOSYSTEMS, INC. tempshield ("Shield") for continuous temperature monitoring device in the Pediatric Emergency Department. Upon inpatient admission decision entry to the emergency department, a Children's National study staff will be approached for interest and presented with the project and all relevant study materials/documents.Through the tempshield system, clinicians can be notified if a patient's temperature exceeds a given threshold.

The tempshield system is centered around a non-invasive temperature sensor placed against the patient's skin, in the pectoral region just below the collar bone. The temperature sensor is held in place with a silicone adhesive tape similar to a custom shaped piece of medical tape. The silicone adhesive tape is hypoallergenic. Once enrolled, the tempshield wearable device will be placed on the upper chest with gentle, silicon adhesive tape. Study staff will ensure that the device is stable on the subject's chest. In the case that the device will not successfully adhere to the patient's chest, the research team will forego the enrollment of that specific subject due to lack of feasibility. The research team will register the wearable device and connect it to the AION BIOSYSTEMS, INC. Shield app via the Samsung A13. A Samsung phone will be kept in the patient's room to track the tempreature from the device. This phone is used for recording the Oral temperatures taken by the study staff.

Upon activation of the tempshield, participants will be given 60 minutes for the tempshield to acclimate to the environment before an oral temperature measurement is taken. The oral temperature will be taken by the research team using a Welch Allyn 901053 Oral Thermometer and input information into the AION BIOSYSTEMS, INC. app. After the acclimation period, the first measurement of oral temperature using the Welch Allyn oral thermometer will be recorded in the AION BIOSYSTEMS, INC. Shield app by the research team. Following this, measurements of the tempshield sensor temperature will be recorded in the AION BIOSYSTEMS, INC. Shield app 1 ±5 minutes apart. Research coordinators will measure oral temperatures every 2 hours ±1 hour for up to a 24hour period, with a maximum of 6 recordings per pt.. A patient's participation will end once they are discharged from the ED or after 7 hours, whichever comes first. If the patient is moved to in-patient unit, the research coordinator will remove the device from the participant. After 7 hours or at the time of ED discharge, the device will be removed from the participant. If there is no height listed in the EMR, research staff will measure participant height.

In addition to collecting oral temperature every 2 hours, research staff will also recheck placement of AION BIOSYSTEMS, INC. device in adhesive to ensure that the device is still stable in place. If adhesive is not stable, research staff will replace the adhesive with new strip. Research staff will check with LAR to make sure that device was not removed or did not fall off. If device was removed or had fallen off, research team will document estimated time of removal and replacement on CRF and the reasoning for the device displacement. If the device is damage and unable to be used, , the device will be replaced, and the enrollment will continue for the duration of the 7 hours. Otherwise, the same device will be used on the subject throughout the enrollment even if it falls off or is removed from the subject.

Conditions

Fever; Sepsis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aion Tempshield Device

Group Type: EXPERIMENTAL

Aion Tempshield Device

Intervention Type: DEVICE

The AION BIOSYSTEMS, INC. tempshield is a skin-applied, continuous temperature monitor. It is battery powered, communicates using Bluetooth LE to a smartphone, then to a clinician dashboard, and is designed to be worn continuously for up to 60 days. Its primary use is for patient monitoring in hospital or post-discharge from a healthcare facility. Through the tempshield system, clinicians can be notified if a patient's temperature exceeds a given threshold. The tempshield system is centered around a non-invasive temperature sensor placed against the patient's skin, in the pectoral region just below the collar bone. The temperature sensor is held in place with a silicone adhesive tape similar to a custom shaped piece of medical tape. The silicone adhesive tape is hypoallergenic.

Interventions

Aion Tempshield Device

The AION BIOSYSTEMS, INC. tempshield is a skin-applied, continuous temperature monitor. It is battery powered, communicates using Bluetooth LE to a smartphone, then to a clinician dashboard, and is designed to be worn continuously for up to 60 days. Its primary use is for patient monitoring in hospital or post-discharge from a healthcare facility. Through the tempshield system, clinicians can be notified if a patient's temperature exceeds a given threshold. The tempshield system is centered around a non-invasive temperature sensor placed against the patient's skin, in the pectoral region just below the collar bone. The temperature sensor is held in place with a silicone adhesive tape similar to a custom shaped piece of medical tape. The silicone adhesive tape is hypoallergenic.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AION Biosystems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000455

Identifier Type: -

Identifier Source: org_study_id