In this study, we to confirm the cuff design and make sure it works. Aspects such as safety and ease of use are also evaluated.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
N/A, measurement of blood pressure with a finger cuff
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As the study is an early feasibility data collection, the primary outcome of
the study is the confirmation that the design works and is able to measure
blood pressure continously and non-invasively in children 0-2 years old.
Measurement accuracy is determined by comparing the ClearSight blood pressure
reading to a standard blood pressure reading.
Secondary outcome
Aspects such as ease of use will also be evaluated
Background summary
It has been possible for some time to continuously measure blood pressure in
adults with a cuff around a finger (ClearSight technology, Edwards
LifeSciences). An advantage of this measurement is that it is possible to
monitor a patient's blood pressure continuously, rather than with an upper arm
cuff that inflates once every few minutes. Another advantage is that it is not
necessary to give an extra injection to place a catheter in the artery of the
wrist.
In young children (0-2 years old) this method of measurement is not yet
available. Recently, the company Edwards LifeSciences (Irvine, CA, USA)
developed prototype cuffs that can be applied in children 0-2 years old. The
principle of operation and the materials used are identical to the standard
cuffs used in adults. About 10 years ago, a first exploration was made of
measurements with a cuff around the finger in children (please refer to section
K4-Scientific Papers in the Reseach file). No safety risks were observed during
these measurements. The current prototype cuffs have now been developed based
on this earlier experience.
The current study is an exploration of the feasibility of the design of newly
developed prototype cuffs in children 0-2 years. The data will be used to
estimate the feasibility of a larger follow-up study at a later stage.
Study objective
In this study, we to confirm the cuff design and make sure it works. Aspects
such as safety and ease of use are also evaluated.
Study design
This Study is a prospective, single-arm, observational data collection Study at
1 Study site in the Netherlands to evaluate a prototype ClearSight finger cuff
in pediatric patients under 2 years of age
The examination takes approximately 30 minutes.
Step 1: The researcher, a doctor from the AMC, selects the child.
Step 2: The parent/legal representative gives permission to the researchers to
carry out the measurements. At any time, without giving reasons, a parent/carer
can decide to stop the study.
Step 3: Measurements will be taken with the prototype cuffs during anesthesia
for the child's planned surgery. The blood pressure is measured with a cuff
around a finger (index finger, middle finger, ring finger) in a period of up to
30 minutes. Anesthesia will not be changed or extended for this study. During
this time, cuffs may be changed and the cuff may be tested on different fingers.
In addition to the researcher from the AMC, a researcher from Edwards
Lifesciences can be present at the measurement.
During the examination, the child will receive standard care. No post-checks
are necessary.
Study burden and risks
Blood pressure is measured on the finger for a limited time and under
anesthesia for a planned surgery in a setting where the investigator is present
at the measurement, therefore there is no real burden and additional risk
involved. Cf. E9 for a list of risks and mitigations.
One Edwards Way 1
Irvine, California 92614
US
One Edwards Way 1
Irvine, California 92614
US
Listed location countries
Age
Inclusion criteria
Children in the age 0-2 years during anesthesia for a planned surgery
Exclusion criteria
1. Any significant disfigurement or prior injury to a participant*s finger that
is intended to be used for monitoring with the prototype finger cuff
2. Inability to place finger cuffs appropriately due to subject anatomy,
condition, or obstructive paraphernalia
3. Known sensitivities to system materials
4. Broken or open skin located at the site of the finger cuff
5. Proven left*right difference in blood pressure
6. Cardiac problems that can cause a difference in blood pressure between the
two arms, including aortic coarctation
7. Extreme contraction of the smooth muscles in the arteries and arterioles of
the lower arm and hand, such as may be present in patients with Raynaud*s
disease
Design
Recruitment
Medical products/devices used
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 | NL85126.018.23 |