NCT04821362

Comparison of Different Techniques on First Attempt Success in Difficult Vascular Access Patients

Completed NA Results posted Last updated 3 December 2021

What this trial tests

NA trial testing Ultrasound group in Vascular Access in 270 participants. Completed in 1 March 2020.

Timeline

15 April 2019

Primary endpoint
1 February 2020

1 March 2020

Quick facts

Lead sponsor	Ege University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	270
Start date	15 April 2019
Primary completion	1 February 2020
Estimated completion	1 March 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Ultrasound group
• Near Infrared Device Group

Conditions studied

• Vascular Access — all drugs for Vascular Access →

Sponsor

Ege University

Who can join

18 and older, any sex, with Vascular Access. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Success in the First Attempt Primary · From the time of randomization until the time of the first successful attempt, up to 30 minutes.

The success numbers of the first attempt during the implementation of all three methods

Group	Value	95% CI
Standard Technique Group	56
Ultrasound Group	71
Near Infrared Device Group	53

Procedure Time. Secondary · From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.

Time of the intravenous catheter placement procedure

Group	Value	95% CI
Standard Technique Group	72	47 – 134
Ultrasound Group	107	69 – 228
Near Infrared Device Group	82	61 – 163

Patients Who Need Rescue Methods Secondary · Up to 1 hour.

The method used as a rescue method when the primary method fails to achieve success.

Group	Value	95% CI
Standard Technique Group	17
Ultrasound Group	17
Near Infrared Device Group	25

Number of Attempts Secondary · From the time of randomization until the time of the successful attempt, up to 1 hour.

Number of attempts to successfully insert peripheral vascular cateter.

Group	Value	95% CI
Standard Technique Group	1	1 – 2
Ultrasound Group	1	1 – 1
Near Infrared Device Group	1	1 – 2

Sponsor's own description

The aim of this study is to investigate whether there is any difference between the use of standard techniques, ultrasonography and infra-red light for the success of the first attempt in difficult peripheral vascular access patients. Patients who have difficult vascular access history ( often need 2 or more attempt to access peripheral intravenous catheter), who do not have palpable or visible vein after tourniquet, and who have the hard anticipation according to operator ( easy-moderate-hard) are included to study. The primary objective is planned as the determination of the success rate in the first attempt. Secondary aims of the study were determined as: total procedure time,total number of attempts, and need for rescue procedure

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.