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

NCT05265481 | Completed

• 1 other identifier: IRB202102042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Catheterization, Peripheral; Venous Dilatation

Keywords

Catheterization, Peripheral; Massaging; Tapping; Tourniquet; Venipuncture; Venodilation

Outcome Measures

Primary Outcomes (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.

  2 hours

Secondary Outcomes (1)

• Change in the effect of tourniquet application

  2 hours

Study Arms (4)

Baseline

NO INTERVENTION

In this phase, the investigators will not apply any venodilation method.

Tourniquet applied

ACTIVE COMPARATOR

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

Device: Tourniquet

Tourniquet plus manual tapping

ACTIVE COMPARATOR

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein manually.

Device: Tourniquet; Device: Manual Tapping

Tourniquet plus device tapping

EXPERIMENTAL

The investigators will apply a pressure cuff tourniquet inflated to 60 mmHg plus tapping directly over the vein with a massage device.

Device: Tourniquet; Device: Device tapping

Interventions

Tourniquet DEVICE

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

Tourniquet applied; Tourniquet plus device tapping; Tourniquet plus manual tapping

Manual Tapping DEVICE

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

Tourniquet plus manual tapping

Device tapping DEVICE

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

Tourniquet plus device tapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32601, United States

Location

Related Publications (3)

• 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.

  PMID: 31222981 BACKGROUND

• 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.

  PMID: 24724700 BACKGROUND

• 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.

  PMID: 25899629 BACKGROUND

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Brandi Lattinville

  University of Florida

  STUDY DIRECTOR

• Yahya A Acar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 3, 2022
• Study Start: November 7, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)