Clinical trial NCT04027218: Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venipuncture
Healthy Adult
Keywords: venipuncture
hemolysis
heat
pressure
safety
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
First posted: 2019-07-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Signed the informed consent form for bioequivalence study
* Signed the informed consent form for this clinical trial
* Fluid intake of participants was limited to a volume equal to or less than 500 ml
* Participants fasted 6-8 hours before venous cannulation
* Body mass index (BMI) between 18.5-29.9
* Vein perception by Venous International Assessment (VIA) scale between 5 to 2 grade.

Exclusion Criteria:

* Grade one in VIA scale
* Smokers
* BMI lower than 18.5 or equivalent or higher than 30
* Subjects who had any disease,
* Blood test, urinalysis, physical examination or electrocardiogram showing disorders with clinical relevance
* Subjects receiving treatment for anything apart from contraceptives.
* Gluten, lactose intolerance, vegetarian or vegan subjects for bioequivalence subjects.

Primary outcomes:
measure: Number of Participants With Successful Venous Catheterization at the First Attempt
timeFrame: From 1-5 minutes
Secondary outcomes:
measure: Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention
timeFrame: up to ten minutes after application of intervention
measure: Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention
timeFrame: up to 2 hours after application of intervention
measure: Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
timeFrame: up to 2 hours after application of intervention
measure: Level of Hemolysis in Absorbance Units
timeFrame: up to 9 days after first intervention completion
measure: Number of Participants With Adverse Events
timeFrame: During the study completion,. an average of 30 days.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Leticia Carmen Simón López
Study officials:
affiliation: Universidad Complutense de Madrid
name: Leticia Carmen Simón López, RN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Impact of the phlebotomy training based on CLSI/NCCLS H03-a6 - procedures for the collection of diagnostic blood specimens by venipuncture. Biochem Med (Zagreb). 2012;22(3):342-51. doi: 10.11613/bm.2012.036.
citation: Shah JS, Soon PS, Marsh DJ. Comparison of Methodologies to Detect Low Levels of Hemolysis in Serum for Accurate Assessment of Serum microRNAs. PLoS One. 2016 Apr 7;11(4):e0153200. doi: 10.1371/journal.pone.0153200. eCollection 2016.