Primary Objective: Examine the accuracy of generated temperature values with three devices (Exergen, Braun and Genius) in concordance to rectal temperature in patients admitted to the Emergency Department (ED). Secondary Objective: Recommend the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
temperatuur
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Measuring the accuracy of generated temperature values using Exergen
TAT-5000 (temporal artery), Genius 3 (tympanic membrane), the Braun ThermoScan
6520 (tympanic membrane), in concordance to Thermoval Rapid (rectal).
Secondary outcome
Demographic characteristics * age, sex, body mass and stature - will be
retrieved from the participant by the student researcher, and used as
confounder in the analysis
Background summary
Fever (temperature of the human body core exceeding 38°C) is a common symptom
of several medical conditions and in particular infectious diseases (Kluger et
al., 1998). The temperature measurement device should be reliable and easy to
use.
Reliable methods are rectal and oesophageal measurement methods, but these are
not user nor patient friendly. Consequently, other over-the-counter methods are
dominating the market and sales increase during influenza outbreaks (Villamarín
et al., 2013). Commonly used non-invasive methods include infrared measures on
the forehead or in the ear. Although various studies showed that these devices
are accurate when calibrated, the temperature measured in humans is often not
corresponding to a golden standard such as rectal and oesophageal thermometers
that give consistent readings in exercise studies (Daanen, 2006; Kistemaker et
al., 2006; Teunissen et al., 2011) and clinical studies (e.g., (Lefrant et al.,
2003)). As a consequence, an inaccurate measurement could mean that any
necessary policy to be started is delayed or not started at all, with all the
associated problems.
Therefore, the Faculty of Behavioral and Movement Sciences of VU Amsterdam was
approached by clinical physicists from three academic hospitals (Amsterdam,
Groningen and Leiden) to investigate the three most common used systems. The
first study was conducted under controlled lab conditions in which 1) the
systems were calibrated and 2) body core temperature in healthy subjects was
increased to values of 38°C (Koning, 2021).
The pilot study gives an idea of possible shortcomings of the systems used in
academic hospitals, but the proof of the pudding is in clinical measurements.
This second study will be a method comparison study as described hereafter
Study objective
Primary Objective: Examine the accuracy of generated temperature values with
three devices (Exergen, Braun and Genius) in concordance to rectal temperature
in patients admitted to the Emergency Department (ED).
Secondary Objective: Recommend the academic hospital on which device is best to
use.
Study design
A method comparison study will be conducted, using four different temperature
measuring devices (Braun, Exergen, Genius and Thermoval Rapid
Study burden and risks
There are no risks foreseen in participation since patients in critical
conditions are excluded
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Participants must meet the following criteria:
* 18 years or older
* According to the applied triage protocol, measurement of temperature will
already be a necessary test given the entry-complaints, assessed by emergency
department nursing staff.
* The attending physician may request temperature measurement for diagnostic
reasons.
* Proficiency in Dutch or English language, or accompanied by an (in)formal
caregiver proficient in these languages.
Exclusion criteria
Participants who meets any of the following criteria will be excluded:
* Inability to give consent, due to life-threatening situations or reduced
consciousness,
* Incapacitated patients, i.e. patients who do not understand the information
about their illness, treatment; cannot decide for themselves or do not
understand the consequences of a decision,
* pregnancy
* congenital or acquired anomaly of the external auditory meatus
* diseases of the ear.
* participants with haemorrhoids to avoid discomfort and possible bleeding
during rectal measurements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79962.018.22 |