Continuos Body Temperature Monitoring

Fever Clinical Trial

Official title:

Examination of a Telemedicine System for Continuous Monitoring of Body Temperature in Adults - a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447337
• Other study ID #: BABYFM-010
• Status: Not yet recruiting
• Start date: June 10, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Baby FM Doo
• Contact: Ivan Soldatovic
• Phone: +381641772077
• Email: soldatovic.ivan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a nonrandomized, diagnostic, single-center, pilot study, with one group of participants. The aim is to examine the effectiveness and safety of telemedicine system for continuous measurement of body temperature in adults. Up to 40 subjects will participate in this phase of the clinical trial. No stratification, nor randomization of subjects will be performed. Respondents who meet the inclusion criteria will be monitored for up to 72 hours plus 72 hours after removing the device. Namely, the device will be placed on their body and will be there until upt to 72 hours, and then it will be removed. The respondent will be monitored by the team for an additional 72 hours by the person in charge of the examination, for possible side effects.

Sensor will be placed in the axilar joint or a little below on the side. The device will be connected to a mobile phone. Member of the research team (principal researcher/co-researcher/ nurse in charge of examination) measures the temperature of the skin in the opposite armpit manually, ie with a gallium thermometer and records every 30-60 minutes. When body temperature starts to rise, a member of the research team measures the body temperature every 15-30 minutes. After reaching a stable temperature, the temperature is measured every 30-60 minutes. If the subject is given drugs to lower body temperature, the temperature is measured again every 15-30 minutes until the temperature stabilizes to a normal subfebrile state.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A person of male or female sex

• Age 18 and over

• Ability to measure the patient's body temperature frequently

• People who are hospitalized due to any type of infection or any other diseases that result in variations in body temperature (rise, fall)

• Completed all potential diagnostics of the hospitalized patient (no interrupting the measurement of the telemedicine device)

Exclusion Criteria:

• Allergic to contact with plastic or silver

• Anatomical anomalies that prevent the placement of the system

• High-risk health conditions, intensive care and the like

• A pacemaker or other device on the skin or implanted in the body that emits light electromagnetic radiation

Related Conditions & MeSH terms

• Fever

Intervention

Diagnostic Test:
• Continous body temperature monitoring
The investigational product will be placed on the participants' body in axilar joint and connected to the mobile phone. The values of the current temperature will apear on the monitor and it will be recorded in the database with date and time for each record. In parallel, study staff will occasionally measure the temperature using standard hospital thermometer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baby FM Doo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between device for continous body temperature monitoring and standard thermometer	The correlation between temperature measurements with the standard hospital thermometer (with galium) is expected to be high	up to 72 hours
Secondary	Frequency of device and procedure related adverse events	The number and percentage of adverse events related to the investigational product will be evaluated and summarized.	up to six days