VenipunctureECYPVEN-H/17NCT04027218
Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
A study testing Dry heat, High pressure and Combination of dry heat and high pressure in people with Venipuncture and Healthy Adult, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Venipuncture, Healthy Adult
- What is being tested?
- Dry heat, High pressure and Combination of dry heat and high pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jul 2017to 3 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read more
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:
- To Apply local dry heat.
- To apply high tourniquet pressure.
- 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.
Read the 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.
- Conditions
- Venipuncture, Healthy Adult
- Being tested
- Dry heat, High pressure, Combination of dry heat and high pressure
- Keywords
- venipuncture, hemolysis, heat, pressure, safety
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry heatDevice
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.
High pressureDevice
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.
Combination of dry heat and high pressureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Current clinical practice-Dry heat | Active comparator | The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
1 period (current clinical practice) and 2 period (dry heat) or 1 period (dry heat) and 2 period (current clinical practice). Receives: Device: Dry heat |
| Current clinical practice- Hihg pressure | Active comparator | The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
1 period (current clinical practice) and 2 period (high pressure) or 1 period (high pressure) and 2 period (current clinical practice). Receives: Device: High pressure |
| Current clinical practice-Combination | Active comparator | The standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital.
1 period (current clinical practice) and 2 period (combination of dry heat and high pressure) or 1 period (combination of dry heat and high pressure) and 2 period (current clinical practice). Receives: Device: Combination of dry heat and high pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Venous Catheterization at the First Attempt
Number of participants with successful venous catheterization at the first attempt (effectiveness)
Measured: From 1-5 minutes
Secondary outcomes (5)
Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention
Vein perception in VIA scale was considered as the self-reported visual observation or palpation of a venous pathway.
Subjects were graded using the current clinical practice vein stagnation with an elastic compressor application (Unidix®).
Five grades considering the numbers of points of optimal puncture visible and tangible, in one of the dorsal veins of the hand, forearm cephalic and/or basilic.
Grade I: At least six. Grade II: At least four. Grade III: At least three. Grade IV: At least one. Grade V: None.
Therefore, the best grade is I, and the worst grade is V. Higher scores mean a worse outcome.
Measured: up to ten minutes after application of intervention
Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention
Visual Analogue Scale (VAS) in pain was measured by integer number. Pain was self-expressed by participants, in a range from 0 to 10.
10: was considered the worst pain experienced 0: no pain perceived.
The entire range was 0, 1, 2, 3, 4, 5 , 6, 7, 8, 9, 10.
Therefore, higher scores mean a worse outcome.
Measured: up to 2 hours after application of intervention
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Number of participants in each type of skin standardized according to Fitzpatrick scale. Fitzpatrick scale is the UNABBREVIATED scale that indicates different types of skin described as "phototypes". The individuals were graded clinically by sel-expressed by participants in the area of the forearm not exposed to the sun.
In a range of six phototypes, where phototype I corresponds with the minimum and phototype VI the maximum.
Phototype I: Ivory white, burns easily, never tans. Phototype II: White, burns easily, tans minimally with difficulty. Phototype III: White, burns moderately, tans moderately and uniformly Phototype IV: Beige-olive, lightly tanned, burns minimally, tans moderately and easily.
Phototype V: Rarely burns, tans profusely. Phototype VI: Dark brown or black, never burns, tans profusely.
Phototype I was considered more risky outcome for expected adverse events in skin. None was considered better or worse outcome.
Measured: up to 2 hours after application of intervention
Level of Hemolysis in Absorbance Units
Detection level of absorbance values of hemolysis in plasma samples. The units of absorbance are dimensionless. The hemolysis in plasma is analyzed by spectrophotometry method, using a NanoDrop® 2000 Spectrophotometer device (Thermo Fisher Scientific Inc., Wilmington, United States of America).
The following equation was used to correct lipemia: (A414-A385) +0.16xA385. Additionally, a baseline correction factor at 750 nanometer wavelength was applied. Therefore, absorbance were measured at 414 nanometer, 385 nanometer and 750 nanometer.
Higher values represent a worse outcome: higher value mean higher hemolysis in a blood sample.
Therefore, lower values, near to zero are better outcomes that mean low hemolysis in blood sample.
Measured: up to 9 days after first intervention completion
Number of Participants With Adverse Events
Number of adverse events by visual inspection.
Measured: During the study completion,. an average of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start9 Jul 2017
- Primary completion23 Jul 2017
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Responsible party
- Sponsor
- Investigators
- Leticia Carmen Simón López, RN, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027218
- Sponsor's protocol ID
- 3113
- Acronym
- ECYPVEN-H/17
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is all individual participant data (IPD) that underlie results in a publication. Also, if any volunteer ask for her/his results specifically, a report will be provided.
Publications
de la Torre-Montero JC, Montealegre-Sanz M, Faraldo-Cabana A, Oliva-Pellicer B, Garcia-Real I, Fenwick M, Marcos Caceres E, Rivas-Eguia B, Vila-Borrajo C, Valles-Andres J, Alonso-Gordoa T, Garcia-Carrion C, Diaz-Rubio Garcia E, Beneit-Montesinos JV. Venous International Assessment, VIA scale, validated classification procedure for the peripheral venous system. J Vasc Access. 2014 Jan-Feb;15(1):45-50. doi: 10.5301/jva.5000173. Epub 2013 Sep 4.
PubMed 24043322Eilers S, Bach DQ, Gaber R, Blatt H, Guevara Y, Nitsche K, Kundu RV, Robinson JK. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013 Nov;149(11):1289-94. doi: 10.1001/jamadermatol.2013.6101.
PubMed 24048361Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Fink RM, Hjort E, Wenger B, Cook PF, Cunningham M, Orf A, Pare W, Zwink J. The impact of dry versus moist heat on peripheral IV catheter insertion in a hematology-oncology outpatient population. Oncol Nurs Forum. 2009 Jul;36(4):E198-204. doi: 10.1188/09.ONF.E198-E204.
PubMed 19581223Yamagami Y, Tomita K, Tsujimoto T, Inoue T. Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:1-7. doi: 10.1016/j.ijnurstu.2017.03.009. Epub 2017 Mar 27.
PubMed 28410510Lima-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.
PubMed 23092065Shah 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.
PubMed 27054342Simon-Lopez LC, Ortuno-Soriano I, Luengo-Gonzalez R, Posada-Moreno P, Zaragoza-Garcia I, Sanchez-Gomez R. Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial. JMIR Res Protoc. 2025 Feb 10;14:e56062. doi: 10.2196/56062.
PubMed 39927682
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04027218
- Acronym / sponsor ID
- ECYPVEN-H/17 / 3113
- Conditions
- Venipuncture, Healthy Adult
- Keywords
- venipuncture, hemolysis, heat, pressure, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Study start
- 9 Jul 2017 (actual)
- Primary completion
- 23 Jul 2017 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To Apply local dry heat.
- To apply high tourniquet pressure.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current clinical practice-Dry heat | Active comparator | Device: Dry heatThe standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital. 1 period (current clinical practice) and 2 period (dry heat) or 1 period (dry heat) and 2 period (current clinical practice). |
| Current clinical practice- Hihg pressure | Active comparator | Device: High pressureThe standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital. 1 period (current clinical practice) and 2 period (high pressure) or 1 period (high pressure) and 2 period (current clinical practice). |
| Current clinical practice-Combination | Active comparator | Device: Combination of dry heat and high pressureThe standardized and approved CLSI GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital. 1 period (current clinical practice) and 2 period (combination of dry heat and high pressure) or 1 period (combination of dry heat and high pressure) and 2 period (current clinical practice). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry heatThe 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. | Device | Current clinical practice-Dry heat |
| High pressureIt 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. | Device | Current clinical practice- Hihg pressure |
| Combination of dry heat and high pressureThe 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. | Device | Current clinical practice-Combination |
Primary outcome
Number of Participants With Successful Venous Catheterization at the First Attempt
Time frame: From 1-5 minutes
Number of participants with successful venous catheterization at the first attempt (effectiveness)
5 secondary outcomes
Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention
Time frame: up to ten minutes after application of intervention
Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention
Time frame: up to 2 hours after application of intervention
Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale
Time frame: up to 2 hours after application of intervention
Level of Hemolysis in Absorbance Units
Time frame: up to 9 days after first intervention completion
Number of Participants With Adverse Events
Time frame: During the study completion,. an average of 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24043322de la Torre-Montero JC, Montealegre-Sanz M, Faraldo-Cabana A, Oliva-Pellicer B, Garcia-Real I, Fenwick M, Marcos Caceres E, Rivas-Eguia B, Vila-Borrajo C, Valles-Andres J, Alonso-Gordoa T, Garcia-Carrion C, Diaz-Rubio Garcia E, Beneit-Montesinos JV. Venous International Assessment, VIA scale, validated classification procedure for the peripheral venous system. J Vasc Access. 2014 Jan-Feb;15(1):45-50. doi: 10.5301/jva.5000173. Epub 2013 Sep 4.
- Background: PubMed 24048361Eilers S, Bach DQ, Gaber R, Blatt H, Guevara Y, Nitsche K, Kundu RV, Robinson JK. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013 Nov;149(11):1289-94. doi: 10.1001/jamadermatol.2013.6101.
- Background: PubMed 21856077Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Background: PubMed 19581223Fink RM, Hjort E, Wenger B, Cook PF, Cunningham M, Orf A, Pare W, Zwink J. The impact of dry versus moist heat on peripheral IV catheter insertion in a hematology-oncology outpatient population. Oncol Nurs Forum. 2009 Jul;36(4):E198-204. doi: 10.1188/09.ONF.E198-E204.
- Background: PubMed 28410510Yamagami Y, Tomita K, Tsujimoto T, Inoue T. Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:1-7. doi: 10.1016/j.ijnurstu.2017.03.009. Epub 2017 Mar 27.
- Background: PubMed 23092065Lima-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.
- Background: PubMed 27054342Shah 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.
- Derived from this study: PubMed 39927682Simon-Lopez LC, Ortuno-Soriano I, Luengo-Gonzalez R, Posada-Moreno P, Zaragoza-Garcia I, Sanchez-Gomez R. Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial. JMIR Res Protoc. 2025 Feb 10;14:e56062. doi: 10.2196/56062.
- Individual participant dataSharing planned: Yes. The plan is all individual participant data (IPD) that underlie results in a publication. Also, if any volunteer ask for her/his results specifically, a report will be provided.
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Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Carmen Simón López, RN principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry heat, High pressure and Combination of dry heat and high pressure in people with Venipuncture and Healthy Adult, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Venous Catheterization at the First Attempt (time frame: From 1-5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027218, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.