Venipuncture Clinical Trial
Official title:
Cross-over Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure With Current Clinical Practice for Venipuncture, and Blinded for Evaluating Their Impact on Hemolysis
Low level intervention health products clinical trial, fourth phase, non-commercial research.
Dissertation of COMPLUTENSE UNIVERSITY of Madrid.
Principal Investigator of this clinical trial: Ms. LETICIA CARMEN SIMÓN LÓPEZ Collaborative
investigators: Dr. DOLORES OCHOA-MAZARRO (principal investigator of bioequivalence clinical
trial), and Sir. SERGIO LUQUERO-BUENO (collaborative researcher)
The setting is Clinical trials Unit of Clinical Pharmacology Department. LA PRINCESA HOSPITAL
of Madrid. Research Ethical Committee of LA PRINCESA HOSPITAL of Madrid. Any person will
monitor this clinical trial because the sponsor and principal researcher are the same person.
Nevertheless, an adherence to this protocol will ensure by principal researcher and
co-researchers.
The three interventions are:
1. To Apply local dry heat.
2. To apply high tourniquet pressure.
3. To apply both of them. (Dry heat and high pressure) The common comparator: Current
Clinical practice for peripheral venous catheterization.
The main hypothesis: The number of attempts of success venipuncture at first time are
influenced by any of the interventions applied before.
The main goal: To identify the most effective intervention of applying dry local heat and/or
high tourniquet pressure in relation of number success venipuncture attempts, compared to
current clinical practice.
Design: An experimental, randomized study which is controlled with current clinical practice
to insert a peripheral vein catheter. It is an incomplete cross-over clinical trial, with
three arms which are involved interventions and a common comparator.
Population: Adult healthy subjects. Sample size: It is required to enroll 54 subjects with a
95% of level of confidence and 80% level of power.
Main variable: Succeed peripheral vein catheter insertion at first attempt.
Effectiveness assessment: The optimal effectiveness is considered when vein cannulation
success at first attempt exceeds 95% applying any of the interventions.
Planned date to address: It is planned to carry out around June and/or July of 2017 for the
main variable.
The study is considered a low level intervention clinical trial to evaluate the use and
safety of a sanitary product marketed and accredited for a different aim, but according to
their rules of using.
It is experimental, randomized and controlled study with the usual technique of inserting a
venipuncture catheter until now. Incomplete clinical trial, blind to third parties, in
healthy volunteers, which consists of three arms, in which they are intervened and the
comparator is applied. The volunteers comes from a bioequivalence clinical trial for testing
a new drug, and a venous catheter is required in two period between a wash-out period of one
week, approximately.
For each volunteer one of intervention is applied in one period, and in other period the
comparator is applied. Thus, one intervention and the sequence of one intervention
application and comparator is assigned by randomization using sealed envelopes. Randomization
is only performed in first period, in second period one intervention or comparator assigned
in applied. Thus, each one volunteer is her/his own comparator
. Before assigned intervention or comparator is applied, a Venous International Assessment is
carried out using Venous International Assessment (VIA) validated scale by nurse perception
and palpation. After assigned intervention, another VIA is performed. Then, when peripheral
venous catheterization is achieved, a blood sample is withdrawn in order to examine
hemolysis. Afterwards, pain is registered by Visual Analogue Scale (VAS) validated scale
within no more than two hours from vein catheterization, and skin perception is evaluated by
Fitzpatrick's scale (only in first period) in order to analyze a possible relationship with
adverse events on skin. Subjects are followed-up for 72h in order to monitor adverse events
if applicable.
According to hemolysis, an ethylene diamine tetra acetate (EDTA) blood sample is processing
at 3400 revolutions per minute at 4 Celsius grades for 10 minutes, and plasma samples are
frosted for 24-48h. Afterwards, they are defrosted, and analyzed by absorbance using NANODROP
SPECTROPHOTOMETER. The analysis by spectrophotometer is blinded of intervention or comparator
used to withdrawn.
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