Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
Condition: Venipuncture; Healthy Adult
MeSH terms: Hemolysis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dry heat; High pressure; Combination of dry heat and high pressure
Intervention type(s): Device; Device; Device
Intervention description(s): The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.; It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.; The application is made with two sacks of carob seeds during 7 minutes. The sacks may be placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power; according to instructions for use.
After 7 minutes, the pressure is applied with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand QUIRUMED with CE Marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: venipuncture; hemolysis; heat; pressure; safety