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Catheterization, PeripheralTappingNCT05265481

The Effect of Tapping in the Venous Dilatation for Peripheral IV Access

A study testing Tourniquet, Manual Tapping and Device tapping in people with Catheterization, Peripheral and Venous Dilatation, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Peripheral intravenous cannulation (PIVC) is one of the most common interventions in medical practice. Venous dilatation is helpful for successful PIV placement. Several techniques include hot pack application, tourniquet, massaging, and tapping over the vein to increase vein caliber described in the literature. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Tourniquet, Manual Tapping and Device tapping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
7 Nov 2021to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >18 years old,
  • Giving informed consent,
  • COVID-19 vaccinated (proof of vaccination must be shown)

Who cannot join

  • COVID-19 unvaccinated,
  • Having unexplained COVID symptom(s) (This will be assessed by asking the ONE.UF screening questions):
  • Fever or chills
  • Cough
  • Fatigue
  • Muscle or body aches
Show all 13Show fewer
  • Headache
  • New loss of taste or smell
  • Sore throat
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhea
  • Close contact with a COVID-19 patient in 14 days

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32601

Other trials in United States

About this study

Peripheral intravenous cannulation (PIVC) is one of the most common interventions in medical practice. Venous dilatation is helpful for successful PIV placement. Several techniques include hot pack application, tourniquet, massaging, and tapping over the vein to increase vein caliber described in the literature. However, none of them has been rigorously studied. Therefore, there is still no 'best practice' on how to effect vein dilation in a standard way.

This study aims to investigate the effect of standardized tapping on venous dilatation with a massage device compared to manual non-standardized tapping and define a standard tapping technique using a device.

In this study, the investigators also aim to investigate the effect of tourniquet application with and without vein tapping effect on peripheral vein caliber as determined by ultrasound measurement.

Read the detailed description

PIVC is one of the most common medical interventions in daily practice. Even though it seems like it should be an easy procedure, PIVC can be challenging.

Venous dilatation optimizes conditions for successful vein cannulation. Several techniques are described to affect venodilation, but none of them are standardized because they are done manually, and there will be individual variations among clinicians.

Tapping over the vein has been reported as an effective method. It has been hypothesized that tapping affects vein vaso-nervorum activation and local histamine release. Tapping or massage over the cannulation site is readily applied in busy medical practice, with a third of nurses using tapping or massage to promote venodilation. Tapping and massage are effective methods of vasodilatation to make the vein more prominent for venipuncture, with tapping more effective than massage (Ichimura et al.) There are limited data concerning the effect of tapping in PIVC and its standardization. In the current literature, there is no standard technique on how tapping should be performed.

Specific Aims:

  • H0: Standardized tapping with a massage device is not an effective technique to dilate the peripheral veins for PIVC compared to manual tapping.
  • H1: Standardized tapping with a device is a more effective technique to dilate peripheral veins for PIVC compared to manual tapping.

The investigators expect to learn to what degree a tourniquet increases peripheral vein size and to what degree that is augmented by tapping.

Research Plan:

This is a prospective non-randomized, controlled, non-invasive intervention study.

The investigators will visually and also with surface ultrasound inspect the upper extremity. The investigators will not get blood tests or X-rays for study purposes. The investigators will measure the venous diameter of a vein or veins on the back of the hand and deeper within the forearm and in the antecubital fossa using ultrasound. The investigators will use a survey including participant's demographics (age, gender, handedness, smoking history)

The investigators will use a portable ultrasound device (Butterfly iQ+, Butterfly Network, Inc., CT, USA) connected to an iPad to record ultrasound images (as pictures) and measure the diameter and cross-section area of the various veins. The investigators will take vein measurements from the dorsal hand, cubital, and mid-forearm regions. The investigators will take the measurements from the midline of the antecubital, volar side of the forearm, and dorsal hand regions. The investigators will put masking tapes on the skin as a reference point to make all the measurements from the same plane."

Then the investigators will determine the midpoint of the forearm, the antecubital site, and the volar wrist crease. The midpoint of this line will be the mid-forearm vein measurement site. The investigators will use superficial dorsal hand veins of the dorsal metacarpal region for the dorsal hand vein measurements. During the baseline measurements, the investigators will get the best image with ultrasound and then mark the skin to get all the measurements from the same cross-sectional area and place water-resistant tape with a scale.

The investigators will not use ultrasound gel or direct ultrasound probe application to the skin to prevent any possible ultrasound transducer-related venous compression. Instead, the investigators will sufficiently submerge the hand, forearm, and elbow in a fresh room temperature water-filled basin to allow precise vein caliber measurements with an ultrasound probe without any probe contact with the skin. This technique provides high-quality ultrasound images of superficial and deep veins.

The investigators will use a standard adult blood pressure cuff applied to the mid-upper arm statically inflated to 60mmHg to serve as a tourniquet.

The investigators will measure these parameters:

  • AP diameter of the vein
  • The cross-sectional area of the vein
  • Width of the vein The investigators will measure veins from three different locations
  • Anterior antecubital superficial vein
  • Volar mid-forearm region deep vein
  • Dorsal hand superficial vein

The investigators will make the measurements four times for each vein and participant:

  1. Baseline: In this phase, the investigators will not apply any venodilation method
  2. Tourniquet applied: The investigators will apply a blood pressure cuff tourniquet inflated to 60 mmHg pressure.
  3. Tourniquet plus tapping directly over the vein manually
  4. Tourniquet plus tapping directly over the vein with a massage device The investigators will change the 3rd and 4th items between two arms of the same participant. In other words, the investigators will do 1-2-3-4 for a left arm but 1-2-4-3 for the right arm. The investigators will assess whether the order affects the vein diameter by this change. The venous blood pressure cuff tourniquet will not be applied for more than 20 minutes continuously.

The investigators will take photos of the ultrasound vein visualizations and measure the diameter and cross-sectional area. This will have no PHI attached to the ultrasound images.

The investigators will take photos of the skin using a calibration ruler to assess the dilation of the visible veins externally. These photos will not reveal the subject's face or any personally identifiable images or information. After all study procedures are complete on the initial arm, study procedures will be repeated on the opposite arm.

Primary investigators will be responsible for collecting the data.

The investigators will not use the name or identifiable data when entering the data into the software. Rather than that, the investigators will code the participants (E.g., A01, B02). This data will be stored only in the departmental password-protected encrypted share drive. The survey and paperwork, including any participant data, will be stored at the locked drawers in investigators' offices

Being tested
Tourniquet, Manual Tapping, Device tapping
Keywords
Catheterization, Peripheral, Massaging, Tapping, Tourniquet, Venipuncture, Venodilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TourniquetDevice

    The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg

  • Manual TappingDevice

    The investigators will apply tapping directly over the vein manually to increase the vein dimension.

  • Device tappingDevice

    The investigators will apply tapping directly over the vein with a massage device to increase the vein dimension.

Study groups in NCT05265481
Study groupRoleWhat they receive
BaselineNo interventionIn this phase, the investigators will not apply any venodilation method.
Tourniquet appliedActive comparatorThe investigators will apply a blood pressure cuff tourniquet inflated to 60 mmHg pressure.
Receives: Device: Tourniquet
Tourniquet plus manual tappingActive comparatorThe investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein manually.
Receives: Device: Tourniquet; Device: Manual Tapping
Tourniquet plus device tappingExperimentalThe investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein with a massage device.
Receives: Device: Tourniquet; Device: Device tapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in standardized tapping with a device for PIVC

    The primary outcome is to measure the vein diameters after manual and device tapping and detect the change from baseline in vein diameters.

    Measured: 2 hours

Secondary outcomes (1)
  1. Change in the effect of tourniquet application

    Secondary outcome is to measure the vein diameters before and after tourniquet application and detect the change from baseline in vein diameters.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start7 Nov 2021
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators will make the measurements four times for each vein and participant: 1. Baseline: In this phase, the investigators will not apply any venodilation method 2. Tourniquet applied: The investigators will apply a blood pressure cuff tourniquet inflated to 60 mmHg pressure. 3. Tourniquet plus tapping directly over the vein manually 4. Tourniquet plus tapping directly over the vein with a massage device The investigators will change the 3rd and 4th items between two arms of the same participant. In other words, the investigators will do 1-2-3-4 for a left arm but 1-2-4-3 for the right arm.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265481
Sponsor's protocol ID
IRB202102042
Acronym
Tapping
Status last verified
Nov 2022
First submitted
31 Jan 2022
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There will be no Data Safety Monitoring Board (DSMB) or an oversight committee for the study and no individual participant data (IPD) available to other researchers

Publications

  • Yasuda K, Sato S, Okada K, Yano R. The venodilation effects of tapping versus massaging for venipuncture. Jpn J Nurs Sci. 2019 Oct;16(4):491-499. doi: 10.1111/jjns.12261. Epub 2019 Jun 20.

    PubMed 31222981
  • Ichimura M, Matsumura Y, Sasaki S, Murakami N, Mori M, Ogino T. The characteristics of healthy adults with hardly palpable vein--Relations between easy venous palpation and physical factors. Int J Nurs Pract. 2015 Dec;21(6):805-12. doi: 10.1111/ijn.12313. Epub 2014 Apr 14.

    PubMed 24724700
  • Ichimura M, Sasaki S, Mori M, Ogino T. Tapping but not massage enhances vasodilation and improves venous palpation of cutaneous veins. Acta Med Okayama. 2015;69(2):79-85. doi: 10.18926/AMO/53336.

    PubMed 25899629

Questions about this trial

What is this clinical trial studying?

A study testing Tourniquet, Manual Tapping and Device tapping in people with Catheterization, Peripheral and Venous Dilatation, run by University of Florida at 1 site in United States.

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 3 inclusion and 13 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 3 Nov 2022. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in standardized tapping with a device for PIVC (time frame: 2 hours). 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 NCT05265481, which also lists 3 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 3 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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