The primary outcome is the first attempt success ratio of peripheral intravenous catheter placement with the use of the Veinplicity®, when compared to the traditional landmark technique, in patients with a medium-risk profile according to the A-DIVA…
ID
Source
Brief title
Condition
- Other condition
- Therapeutic and nontherapeutic effects (excl toxicity)
Synonym
Health condition
intraveneuze toegang, perifeer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the first attempt success ratio of peripheral
intravenous catheter placement with the use of the Veinplicity® device, when
compared to the traditional landmark technique, in patients with a medium-risk
profile according to the A-DIVA scale. The outcome of interest is to reach a
success ratio of 90% upon inserting a peripheral intravenous catheter by using
the Veinplicity® device, in patients with a medium-risk profile according to
the A-DIVA scale.
Secondary outcome
As secondary objectives, we are interested in the effects on:
* The time needed for intravenous cannulation;
* Patients satisfaction;
* Pain score upon intravenous cannulation;
* Practitioners satisfaction;
* The relation between the success ratio and patients demographics (age, sex,
length, weight, skin color, dominant side, A-DIVA score, medical history and
comorbidities);
* The relation between the success ratio and procedure related data (size of
the vein, size of the inserted catheter, side of cannulation, site of
cannulation).
Background summary
The Veinplicity® device (Physeon, Schaffhausen, Switzerland) is an electrical
stimulation device, which can be used as an adjunct for peripheral intravenous
cannulation. It is said to increase local intravascular blood volume and
therefor improves a practitioners* ability to gain intravenous access. Because
of this statement, we hypothesize that the first attempt success ratio of
peripheral intravenous cannulation will be increased in patients with a
medium-risk profile according to the A-DIVA scale, with the use of the
Veinplicity® device, when compared to the traditional landmark technique.
Study objective
The primary outcome is the first attempt success ratio of peripheral
intravenous catheter placement with the use of the Veinplicity®, when compared
to the traditional landmark technique, in patients with a medium-risk profile
according to the A-DIVA scale.
Study design
This is an observational intervention study. The results of the procedure in
the intervention group, first attempt success ratio upon peripheral intravenous
cannulation in spite of using the Veinplicity® device, will be compared to a
historical control group.
Intervention
Patients included in the current study, even get a peripheral intravenous
catheter inserted. In the intervention cohort, the target vein will not be
dilated with using a tourniquet, but by using the Veinplicity® device, which is
an electrical stimulation device that can be used as an adjunct for peripheral
intravenous cannulation.
Study burden and risks
Major complications of a failed attempt of inserting a peripheral intravenous
catheter are related to the delay of diagnoses and treatment, arterial
punctures, hematomas, paresthesia, or the risk of central venous
catheterization after multiple unsuccessful attempt of peripheral intravenous
cannulation. The use of the Veinplicity® device will for itself not reduce the
risk for this complications, however the risk for complications will be reduced
when the success ratio increases. Using the Veinplicity® device does not expose
patients to additional risks, besides those which can occur during every
intravenous puncture. This study will involve subjects who either has
experienced difficultly with venous access being gained in the past or are
likely to. It is expected that the device will benefit these patients and
others in the future with more first time cannulation success, less time spent
obtaining access, greater patient and clinician satisfaction, reducing the need
for more invasive types of cannulation (central venous cannulation), reducing
the stress that failed cannulation can bring to both the patient and clinician.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
* Patients must be in the age of 18 years or older;
* Patients with a medium risk profile on the A-DIVA scale (score 2 or 3);
* Patients must be conscious and be able to adequately answer questions.
Exclusion criteria
A potential patient who meets any of the following criteria will be excluded from participation in this study:
* Patients in which an intravenous catheter is already inserted on the ward;
* Patients with medical devices in the body (pacemaker, ICD, trans-cerebral electrode placement, electrode placement that applies current to the carotid sinus region, other neurostimulators);
* Patients who do not understand questions or generate adequate data, due to physical or communicational disorders.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL61818.100.17 |
| OMON | NL-OMON24775 |
| OMON | NL-OMON25489 |