Peri-operative, unobtrusive core temperature measurement

Title: Peri-operative, unobtrusive core temperature measurement - clinical pilot trial



Sponsor: Philips Electronics Nederland B.V. acting through Philips Research represented by Henk van Houten



Primary objective

Compare the performances of unobtrusive prototype sensors to CE-marked
oesophageal and/or rectal reference sensor (Covedien Mon-a- Therm, General
Purpose Temperature Probe 400TM) for core body temperature in patients
undergoing surgery in which core temperature management is part of
standard procedure (Applying the covedien oesophageal and/or rectal sensor
is part of this standard procedure).

The study focus is on stability and accuracy of the prototype sensors in
conjunction with different locations. This is one of the preliminary steps to
come to a low-cost and easy-to- use core body temperature measurement
system for in-hospital use.



Secondary objective(s)

(1) To observe the effect of surgery duration and type on the drop in core
temperature.

(2) Observe the comfort and ease of use of the prototype sensor



Devices to be used

1. A commercially available temperature measurement system
manufactured by the company Covidien (Mon-a- Therm, General Purpose
Temperature Probe 400TM, CE-marked) is applied for referencing.This
device is, as part of the standard procedure, placed in the oesophagus
and/or rectal.

a. This system is attached to the standard GE anesthesia monitoring
system (CE-marked) via the official temperature input on the monitor.
b. The data from the GE anesthesia monitoring system are stored in the
electronic patient data managent system every minute. At the end of
each test this data is retreived from this system.

2. A commercial available ear temperature device manufactured by the
company Braun (CE-marked) is applied for referencing during the pre-
operative phase.

3. The components of the newly developed Philips system are:
a. Passive sensors which comprises a sensor spot consisting of
temperature sensors surrounded by silicon. These sensors are
attached to the volunteers skin by the use of an adhesive designed for
medical use.

b. A data recorder (so called “The Squirrel” (CE-marked with cables.
Declaration of Conformity according to EMC directive 2004/108/EC)
logs and stores the electricial signals from the sensors.



Participating
parties and their
roles

The study will be conducted at the Sint Elisabeth Hospital in Tilburg. The
principal investigator at the site of the investigation, GJ. Noordergraaf, will be
responsible for patient inclusion, but will only supervise this. Philips will
provide Igor Paulussen (MPA and research scientist) and Eefje Arts-Hornix
(research engineer) at institution’s site to support the execution of the
research plan, including providing relevant training of the personnel at the
institution’s site (e.g. for use of data logger), and data recording, storage, and
transfer to Philips. From Philips, Calina Ciuhu-Pijlman(project leader), and a
student will also be at the sponsor’s site for the execution of the research plan,
including data analysis and interpretation. From the investigational site, Gerrit
Jan Noordergraaf is appointed for blinding of privacy-sensitive information.



Subjects

We wish to include 40 adult (≥18 years) patients planned to undergo surgery
with temperature management as standard part of the procedure. These
patients are routinely equipped with an oesophageal and/or rectal temperature
sensor. Exclusion criteria are: neuro-trauma, pregnancy, obesity (BMI>40),
and a significant language barrier that prevents the patient from understanding
the Informed Consent.



Investigation
design

Observational study, compliant with ISO 14155.



Investigation
procedures

Patients will undergo planned surgery. This observational pilot study,
compliant with ISO 14155, will not change anything in relation to their care
except for the addition of extra non-invasive prototype temperature sensors
(placed at e.g. neck, forehead, behind the ear). Temperature measurements
from the reference sensors and the prototype temperature sensors are
collected every minute during the surgery. The device connected to the
prototype temperature sensors is not monitoring the patient in the regulatory
meaning of the word, but only records temperature values without displaying
them. Data recording times depend on the duration of surgery and are limited
by the battery life of the data acquisition device. The administration of
medication as well as other potentially important events will be reported on the
case report form.



Milestones

20-06- 2016 Start of the study

01-07- 2016 Inclusion of first patient

01-09- 2016 Inclusion of first 10 patients

15-11- 2017 Inclusion of all 40 patients

30-12- 2017 Analysis and presentation of the data of all patients

30-01- 2018 End of the study

Every minute pre-operative and during surgery

Patients who are undergoing planned surgery in which core temperature management is part of standard procedure (esophageal and/or rectal), will receive extra prototype core temp sensors These sensors are applied in the holding area one hour before the operation starts. Depending on the sensors and it’s shape it can be applied e.g. behind the ear, on the forehead and/or in the neck.