The objective of the study is to explore the performance of the Sensewear device during various levels of activation of the autonomic nervous system and sedation in a population patients admitted to an ICU.
ID
Source
Brief title
Condition
- Other condition
- Cardiac therapeutic procedures
Synonym
Health condition
sedatie op ICU, nav mechanische beademing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the study part where patients are undergoing elective cardiosurgery, the
primary study parameter will be the function of the autonomic nervous system,
which can be evaluated by measurements of the galvanic skin response (with the
Sensewear device) and heart rate variability.
For the study part where other ICu patients are studied, the primary study
parameter will be the depth of sedation, which can be evaluated by measurements
of BIS registration and acceleration (with the Sensewear device0.
Secondary outcome
For both groups of patients, the secundary study parameters will be the other
parameters of autonomic nervous system function as measured with the Sensewear
device.
Background summary
Patients admitted to an Intensive Care Unit are well-monitored to evaluate
their clinical condition. Although in general the so-called vital signs (blood
pressure, heart rate and temperature) are well monitored, there is a paucity of
information on other relevant parameters. This includes, among others,
information on the amount of energy expenditure and scoring of physical
activity. Recent technological developments have resulted in the introduction
of small electronic devices (such as the SenseWear® armband) that provide
non-invasive measures of total energy expenditure and physical activity. This
is based upon recording of skin temperature, the galvanic skin response, the
heat flux and accelerometry.
Study objective
The objective of the study is to explore the performance of the Sensewear
device during various levels of activation of the autonomic nervous system and
sedation in a population patients admitted to an ICU.
Study design
Outline of study activities cardiosurgery patients: Eligible patients will
undergo the scheduled surgical procedure. The only deviation from the routine
care is that an armband with the device will be strapped around their right
upper arm. The armband will be applied for one hour at the evening before
surgery and for a period of 24 hours that will start when the patient is
transferred to the surgery room. Most patients are already commonly monitored
using a BIS-monitor and special attention will be given that all patients
participating in this study will have such a monitor. Also, in these patients
1-lead ECG recordings will be made which will enable to study the Heart Rate
Variability, which is considered a measure for the activity of the autonomic
nervous system.
Outline of study activities ICU patients: Eligible patients will, during the
routine care, be equipped with an armband with the device strapped around their
right upper arm. The armband will be applied for periods of 24 hours. Most
patients are already commonly monitored using a BIS-monitor and special
attention will be given that all patients participating in this study will have
such a monitor.
Study burden and risks
As this experiment is carried out during the routine medical care of the
patients, this implies that all procedures and activities necessary for the
care of the patients will not be altered, so participation in the study will
have minimal burden and risks.
Albinusdreef 2, PO-box 9600
2300 RC Leiden
Nederland
Albinusdreef 2, PO-box 9600
2300 RC Leiden
Nederland
Listed location countries
Age
Inclusion criteria
20 patients scheduled for elective cardiosurgery.
20 patients admitted to the ICU and are receiving sedation medication.
Exclusion criteria
Patients treated with a pacemaker
Design
Recruitment
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 | NL16686.058.07 |