Is pulse rate variability obtained from non-invasive continuous blood pressure measurements comparable to heart rate variability derived from an ECG signal during a battery of autonomic tests in healthy volunteers?
ID
Source
Brief title
Condition
- Other condition
- Diabetic complications
Synonym
Health condition
evaluatie van de autonome functie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between pulse rate variability derived from non-invasive continuous
blood pressure measurements and heart rate variability derived from an ECG
during a standard battery of autonomic tests.
Secondary outcome
Continuous measurements of heart rate and blood pressure
Demographic patient variables: age, weight, length, comorbidities
Background summary
Recently the department of Anesthesiology started a study investigating cardiac
sympathetic innervation and coronary blood flow regulation during anesthesia.
This study will be conducted in healthy subjects and in diabetic patients with
and without cardiovascular autonomic neuropathy (CAN). According to available
literature CAN should be diagnosed with a battery of cardiovascular reflex
tests in which beat-to-beat changes in heart rate are evaluated, i.e. the heart
rate variation (HRV). HRV is usually obtained by measuring the time elapsed
between two consecutive R-waves on the electrocardiogram (ECG). However, in the
department of Anesthesiology a non-invasive continuous blood pressure
measurement device (Nexfin) is available in which heart rate is determined from
the blood pressure pulse rate. In the present study we therefore aim to
investigate whether pulse rate variability (PRV) can be used as a reliable
alternative for heart rate variability.
Study objective
Is pulse rate variability obtained from non-invasive continuous blood pressure
measurements comparable to heart rate variability derived from an ECG signal
during a battery of autonomic tests in healthy volunteers?
Study design
Prospective, observational trial.
Study burden and risks
Nexfin device:
Continuous blood pressure measurements will be performed by placing a finger
cuff around the middle index of the left hand. The hand will be placed in a
comfortable position when the volunteer is in a supine position. ECG-leads will
be attached to the thorax. These techniques are associated with minimal
discomfort for the patient.
Controlled breathing:
Volunteers will perform a cycle of metronome-controlled breathing to mimic
ventilation conditions. This is regarded to induce minimal discomfort.
Valsalva maneuver:
The Valsalva maneuver will be performed by blowing into a manometer-controlled
device that allows standardization of the pressure which induces the Valsalva
effects. This measurement is associated with minimal discomfort.
Quick Standing test:
Volunteers are asked to quickly change from supine to standing position. This
may induce some dizzyness, but in general this test will not cause other
discomfort.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
Sober males
Age 18-35 years
Healthy subjects
Informed consent
Exclusion criteria
BMI > 15 kg/m2 and < 35 kg/m2
Underlying cardiovascular diseases
Use of beta blockers or anti-hypertensive drugs
Diabetes mellitus
Use of coffee or cigarettes 12 hours before the measurements take place
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 | NL28800.029.09 |