Core Body Temperature Clinical Trial
Official title:
Core Body Temperature During Hyperthermia in a Whole Body Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
The primary objective of the proposed study is to determine the use of a wireless method to
monitor and record core body temperature during a Whole Body Hyperthermia treatment,
compared to an indwelling rectal thermometer.
This protocol is intended to study the differences between a rectal temperature probe and an
approved wireless and indigestible thermometer during a WBH session. The current standard in
monitoring core body temperature is the usage of an indwelling rectal thermometer. Many
patients and potential study subjects, however, decline receiving the treatment, due to the
discomfort of using this measuring method and a wireless measuring device would open the
possibility for those patients to receive a treatment. The primary endpoint for example of a
treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C.
However, due to the proximity of the probe to the body's surface, the core body temperature
will vary from the rectal temperature and the comparison between the two methods with a
validation of the wireless device is necessary.
The investigators will monitor subject's physiological outcome from a single Whole Body
Hyperthermia treatment in an open fashion (no placebo/control condition). This study will
include safety assessments 7 days several days prior to or same day as the WBH, and include
follow-up assessments 1 day and 1 week later.
This protocol will allow for the evaluation of a wireless measuring device for core body
temperature and a comparison to the data taken with a rectal thermometer, during a Whole
Body Hyperthermia (WBH) in various subject populations. The primary objective of the
proposed study is a potential change from wired core body temperature measurement with a
rectal thermometer to an indigestible thermometer with wireless technology.
The recent standard for measuring core body temperature during WBH procedures is the use of
an indwelling rectal thermometer to constantly monitor the temperature for safety and for
research reasons. Experiences from different clinics and research groups, including ours,
show a high drop-out rate of potential study participants and patients, because of the
discomfort of self-inserting a rectal thermometer for the treatment in a Whole-Body
Hyperthermia. A wireless and reliable measuring technology would open this treatment for
participants, who are declining their participation due to the indwelling thermometer. This
device will exit the subject's body via bowel movement 1-5 days following ingestion and will
not be reused.
Due to the proximity of the indwelling thermometer to the surface of the body, the
temperature does not reflect the real core body temperature and preliminary data, taking by
our group, suggest a significant, but stable difference between core body temperatures
measured with an indigestible device, compared to the temperature taken with the rectal
probe. WBH treatments, currently studied by our group at the University of Arizona, are of
mild nature and the constant infra-red heating is stopped, as soon as a patient reaches the
rectal temperature of 38.5 C. Due to the fact, that the bodies surface is heated up through
the infrared exposure, the investigators assume, that the core body temperature will be
lower, compared to the rectal temperature. A validation study in 20 subjects therefore is
necessary to determine the differences in the measuring methods. This is especially
important, as the end-point of the treatments is defined by the core body temperature, and
different endpoints by switching from one measuring method to the other, without validation,
would potentially bias the study results.
Receiving a treatment in the WBH machine is of non-significant risk and can be compared to
e.g. a sauna visit or an intense exercise, in terms of the physiological reaction. It is
currently studied by our group for the treatment of Major Depressive Disorder, PTSD and
other chronic illnesses. This trial however will not be limited to only include individuals
with MDD or PTSD, but will allow for an expanded use in all populations (while still
excluding subjects based on safety parameters). The investigators will monitor subject's
physiological and clinical outcomes (if applicable) from a single Whole Body Hyperthermia
treatment in an open fashion (no placebo/control condition). This study will include safety
assessments several days prior to or same day as the WBH, and include follow-up assessments
1 day and 1 week later.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02993666 -
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery
|
N/A |