Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447337
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-02
Brief Title:
Continuos Body Temperature Monitoring
Sponsor:
Baby FM Doo
Organization:
Baby FM Doo
Study Overview
Official Title:
Examination of a Telemedicine System for Continuous Monitoring of Body Temperature in Adults - a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 researcherco-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
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 researcherco-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None