Primary objective:- Bepalen of de nauwkeurigheid van de ROBIN geschikt is voor ademhalingsmonitoring in vergelijking met spirometrie.Secondary objective- Bepalen van het effect van veranderingen in de lichaamssamenstelling op de amplitude van de…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
astma, COPD, slaapapneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Mean difference in measured respiratory rate/volume between ROBIN and
spirometer
Secondary outcome
- Correlation coefficient between respiratory rate/volume between from ROBIN
and spirometer
- Correlation coefficient between changes in body composition and impedance
amplitude (and derived parameters)
- Correlation coefficient between changes activity profiles and errors in
calculated respiratory rate and volume
- Difference in error between electrode configuration 1 and 2 for estimations
of respiratory rate of respiratory volume (see section 8.3 in protocol)
Background summary
Recently, Stichting Imec Nederland developed the ROBIN, an instrument for
measuring respiration. The ROBIN offers possibilities to continuously and
reliably measure respiration. Breathing is measured by determining the
impedance of the upper body.
The impedance of the upper body, and also the accuracy of the ROBIN, are mainly
determined by the composition of the upper body. The composition of the upper
body depends on ratios in muscle, water, fat, air and bone.
The ROBIN can measure both breathing and changes in body composition. This
combination would allow the ROBIN to indicate when a measurement is no longer
reliable. Researchers expect that measurement of impedance alone will not be
sufficient and therefore, in addition to impedance, additional contextual
information such as activity level is also taken into consideration.
In the past, ROBIN has already been tested on healthy subjects. The results
were promising, but under normal circumstances body composition and impedance
do not not change. Patients undergoing bariatric surgery will gradually
experience significant changes in body composition. This scenario offers
(according to the researchers) the biggest change that both sensor module and
algorithms will ever encounter.
The aim of this study is to validate whether chest impedance(as measured with
the ROBIN device) is a suitable method for continuous long-term respiration
monitoring.
Steps are also taken towards the identification of parameters needed to develop
quality indicators and self-learning algorithms. This can ultimately lead to
more suitable methods for measuring respiration accurately.
Study objective
Primary objective:
- Bepalen of de nauwkeurigheid van de ROBIN geschikt is voor
ademhalingsmonitoring in vergelijking met spirometrie.
Secondary objective
- Bepalen van het effect van veranderingen in de lichaamssamenstelling op de
amplitude van de impedantiesignalen.
- Onderzoek of veranderingen in activiteitenprofielen zijn gecorreleerd aan
fouten in de door ROBIN berekende ademhalingsparameters.
Study design
Interventional:
The data required for this study will be gathered from 20 patients undergoing
bariatric surgery. In total, the subjects are measured at five different times
(0, 3, 6, 9 and 12 months after the procedure).
Each session is exactly the same and takes about 30 minutes:
- Weight and body composition are measured with a scale
- Body composition is measured by the ROBIN.
- Several breathing exercises:
- Free breathing
- Breath hold after exhalation
- Chest breathing
- Superficial breathing
- Abdominal breathing
- Slow breathing
- Fast breathing
A spirometer (breathing meter) is also used during the exercises.
After the first measurement, the test subject will receive an activity monitor
(FitBit), a wristband that measures how much test subjects move daily. Test
subjects are asked to wear the FitBit as often as possible during the study. If
not possible, the subject is requested to use the FitBit at least 2 weeks after
each measurement.
Intervention
- Breathing exercises using the ROBIN and spirometer
- Wearing an activity monitor (FitBit)
See section study design
Study burden and risks
No significant risks or immediate benefits are expected for the participants.
In the event that ROBIN should go broke, there is a chance that a small power
surge is experienced by the participant, so far this has not happened yet. The
ROBIN supply voltage is 4.2 V. which is considered safe for contact with the
skin. Furthermore, impedance measurements are carried out under the supervision
of the research assistant.
The additional load for the participants consist of: the time it takes to carry
out the measurements (approx. 30 min per session), removal of ECG electrodes
and wearing the activity monitor
High tech campus 31
Eindhoven 5656
NL
High tech campus 31
Eindhoven 5656
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing a stomach reduction
- Age > 18
- Informed consent
- BMI > 28
Exclusion criteria
- Known allergy to adhesive Ag/AgCl electrodes
- Subjects who are pregnant or likely to become pregnant
- Subjects with implantable devices, such as pacemaker, ICD or implanted infusion pump
- Subjects using medication with with phototoxic side effects.
- Tetracylines
- Doxycycline
- Phenothiazines
- Dacarbazine
- Ketoprofen
- Lomefloxacin
This in order to exclude the possibility of local skin irritation from prolonged irradiation by LED-light (from the activity monitor).
- Patients that do not want to be informed in case of incidental findings.
Design
Recruitment
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In other registers
| Register | ID |
|---|---|
| CCMO | NL61577.015.17 |