Continuos Body Temperature Monitoring
ConditionFever
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaby FM Doo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Up to 40 eligible participants with disease and/or condition that results in body temperature variation will be included in the study.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Continous body temperature monitoring
Diagnostic testThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
up to 72 hoursSecondary outcomes
1
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.
Time frame
up to six daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov