Kontinuerlig kroppstemperaturövervakning
Undersökning av ett telemedicinsystem för kontinuerlig övervakning av kroppstemperatur hos vuxna - en pilotstudie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Other/Not Applicable
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Belgrade, Other/Not Applicable, Serbien, 11000
- University Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Up to 40 eligible participants with disease and/or condition that results in body temperature variation will be included in the study.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation Coefficient
Tidsram: Up to 72 hours
|
The correlation between the Baby FM continuous temperature monitoring device and a reference standard gallium thermometer is expected to be high. The primary outcome was the correlation coefficient using all paired temperature measurements from the overall study population. Participant-level correlation coefficients were also calculated for individual participants. Higher correlation coefficients indicate a stronger linear association between measurements from the two devices. |
Up to 72 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Frequency of Device and Procedure Related Adverse Events
Tidsram: Up to six days
|
The number and percentage of adverse events related to the investigational product will be evaluated and summarized. |
Up to six days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BABYFM-010
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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