Patients in ICU Clinical Trial
Official title:
Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.
The study has 2 phases:
- The Retrospective Phase (50 patients were diagnosed to have sepsis according to our
definition and criteria and 30 patients as a controlled cases )
- The Prospective Phase (600 patients who will be admitted and monitored in ICU in order
to get at least 30 sepsis cases, according to our definition and criteria).
Measurements will be made from the forehead using the TTP's biocompatible sensor Unit that
will be attached to the skin. The SU will transfer data to the MCU.
TTP™ system, which is composed of 2 parts:
- SU - a disposable Sensor Unit patch
- MCU - e reusable Monitor Connecting Unit
The communication between the two units can be wired or wireless. The system to be used in
this study is wired and the two units were connected via a Sensor Unit Cable (SCU).
The SU is attached to the temple area by a biocompatible disposable adhesive. It measures
skin temperature across the temporal artery using several sensors, translates it to
electrical signals and transmits those signals to the MCU. The MCU translates the electrical
signals to core temperature using a special mathematical algorithm which overcomes the
effect of the ambient temperature as well as the thermal properties of a specific patient.
The core temperature as well as any concurrent error in the measurement process is displayed
on the screen of the MCU or transmitted to the hospital VSM. The MCU has a wired connection
to the hospital's VSM using Standard YSI400.
Study Objectives
The objectives of this clinical study are:
- A first objective of the clinical study is to verify the findings of a previously
published study, relating to temperature pattern changes within patients who were
diagnosed having sepsis , prior to its occurrence.
- A second objective is to examine the efficacy and safety of the TTP - a novel
non-invasive core temperature measurement system , as a measure for continues core
temperature monitoring.
- A third objective of the study, is to examine the effectiveness of the TTP as a measure
for detection of temperature changes pattern and to correlate such changes with fever
related to infections such as sepsis.
It is estimated that the study with take 18 months to complete.
Type of Study
- A Retrospective phase.
- A prospective phase
Temperature measurements Measurements will be made from the forehead using the TTP's
biocompatible sensor Unit that will be attached to the skin The SU will transfer data to the
MCU. The TTPTM system will be disinfected before use an alcohol-chlorhexidine solution.
1. The Retrospective Phase, screening temperature data logs of patients who had sepsis or
other fever related infection. Screening period shall be at least 72 hours prior to
sepsis or infection detection. This part shall include 50 sepsis cases and 30
non-sepsis cases as a control.
2. The Prospective Phase, measuring core temperature with the TTP and comparing it with
existing technology such as rectal, esophageal or catheter or skin (by the case). The
temperature data taken from each patient who will have a sepsis or other fever related
infection will be analyzed to find any relation between the temperature pattern change
Any medical care decision (such as microbiology cultures, additional testing, etc) will
be made entirely according to existing reference standard of care. The TTP device will
not influence in any way on ICU physician' decision. The TTP device purpose is only to
record medical data for later evaluation and not to intertwine in medical care given to
participants.
This part shall include up to 600 patients who will be monitored and analyzed during their
stay in the ICU in order to get at least 30 sepsis cases.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01122277 -
Rational Fluid Therapy in Germany
|
N/A |