To assess the clinical feasibility, reliability and validity of the combined barocontrol PPG-NIRS-ECG monitor.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Aandoeningen van de bloeddrukregulatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Baroreflex sensitivity and cerebral autoregulation in patients with symptoms,
compared between those with and without OH
- Baroreflex sensitivity and cerebral autoregulation in patients with OH,
compared between those with and without symptoms
- Collinearity between individual BRS, CAR and orthostatic BP drop magnitude
measurements, separate for the three patient groups
Secondary outcome
- Accuracy of PPG based OH classification, separate for the three patient
groups.
- The Pearson correlation of PPG based BP estimation with the gold standard
Finapres BP measurement between 0-30 seconds after standing up.
- Patient reported convenience, using 1-10 scale.
- The intraclass correlation coefficient of repeats of the same postural change
in the same individual.
Background summary
Orthostatic hypotension (OH) is a systolic blood pressure drop (BP) of more
than 20 mmHg and/or a diastolic BP drop of more than 10 mmHg after standing up,
with a prevalence of 20-50% in geriatric outpatients. It is associated with
clinical symptoms of light-headedness and dizziness, and poor clinical outcome,
such as impaired physical performance, falls and mortality. However, the
relationship between OH and clinical symptoms is not always present on the
individual level, potentially due to the time-varying magnitude of
posture-related BP drops within individuals, and also due to differences in the
efficacy of physiological compensatory systems between individuals, such as
baroreflex sensitivity (BRS, i.e. increased heart rate as a response to a blood
pressure drop)1 and cerebral autoregulation (CAR, i.e. cerebral artery
vasodilation as a response to a blood pressure drop to keep cerebral blood flow
constant). BRS and CAR function may therefore discriminate between patients
with and without symptoms in patients with OH. BRS and CAR should be measured
unobtrusively using portable devices to allow for longer term (e.g. 24 hour)
measurements to capture the time-varying nature of these systems during
postural changes and movement. A custom made combined barocontrol monitor
consisting of finger plethysmography (PPG), near-infrared spectroscopy (NIRS),
ECG and an accelerometer/ gyroscope was made to this end and demonstrated to
produce sensitive and reliable results in young and older healthy adults.
However, its validity, measurement feasibility and reliability in geriatric
outpatients needs to be addressed.
Study objective
To assess the clinical feasibility, reliability and validity of the combined
barocontrol PPG-NIRS-ECG monitor.
Study design
cross-sectional study
Study burden and risks
The extent of burden is limited, consisting of one hour of extra time during a
regular clinical visit to the VUmc. This visit will be part of a geriatric
assessment that is part of daily clinical care. Test conditions comprise
postural changes (standing up from sitting and supine position at different
speeds). The different devices used for the blood pressure (Finapres Nova),
NIRS and PPG measurements are all non-invasive and unobtrusive, being placed
primarily at the forehead, the chest and left arm. The Finapres Nova is CE
approved for clinical use. The NIRS-PPG-ECG combination is not CE approved, but
has low risk, as described in the attached investigational medical device
dossier.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
* Age: between 70 and 90 years
* Cognitive score as clinically assessed using Mini Mental State Examination
(MMSE): > 21 points out of 30.
Exclusion criteria
Patients with the following conditions preventing them from performing the test
conditions will be excluded:
* Body mass index (BMI) > 35
* Neurological diseases causing inability to walk unassisted
* Musculoskeletal
o immobilization for 1 week during the last 3 months
o orthopedic surgery during the last 6 months
* Muscle disorders causing leg muscle weakness
* Any disorder causing chronic pain or pain during walking with pain score > 6
on scale from 1-10
* Severe vision problems, causing inability to walk unassisted
* General
o Acute infections affecting general condition
o Recent hospitalization (<4 weeks)
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 | NL70130.091.19 |