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

October 29, 2021 updated by: Sercan Yalcinli, Ege University

Comparison Of Standart Technique, Ultrasonography And Near-Infrared Light In Difficult Peripheral Vascular Access: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before starting the study, all nurses who work as senior nurse in the emergency department will be informed. All the Emergency Nurses who are willing to participate in the study (the consent form from the nurses who will be included in the study) will be taken pretest to measure their knowledge about ultrasound and infrared light usage for intravenous access. Then, the 4-hours theoretical and 4-hours practical lesson accompanied by an infrared device and a single-operator with horizontal and longitudinal vascular access with ultrasonography will be explained by the experienced Emergency Medicine Specialist to all the senior nurses . Introduction of ultrasonography device in the theoretical training, principles of using, linear probe and its properties, horizontal and longitudinal axis concepts used in the determination of venous structures, principles of determination of venous structures in ultrasonography, differentiation of artery and nerve structures will be explained. The introduction of the device for infrared light, the principles of operation, the distance between the light and operation area and the positioning of the device will be discussed. Practical trainings will be arranged on horizontal and longitudinal axes by using ultrasound on lifeless forearm mannequin. In the practical lesson in the infrared light device, the device will be kept in a proper distance on the live mannequin, being positioned perpendicular to the area to be treated and identification of the vascular structures while the device is operating. After the theoretical and practical training, all of the senior nurses will be evaluated with posttest and the nurses with a success rate of 80% will be included in the study.

Adult patients and/ or their relatives will be included to study if they meet any of the inclusion criteria and accept the consent form. The randomization of the patients according to the number of nurses participating in the study will be determined by the responsible researchers before the study begins. For example, in the study where 10 senior nurses will participate, the number of targeted patients will be at least 270 and 10 boxes specific to each nurse will be created. These boxes will be kept in the senior nurse room. Each box will have 27 different application methods (9 usg, 9 infrared, 9 standard methods). The nurse who accepts to participate in the research will apply the method according to the procedure which will be randomly drawn from this box. In this way, an equal number of procedures will be provided for each nurse and an equal number of procedures will be provided for each nurse.

The application of the procedure on the longitudinal or horizontal axis will be left to senior nurse discretion. In the infrared light approach, 2 applicators will be operated. While holding the auxiliary infra-red light, the practitioner will perform the operation at a distance of 20 cm perpendicular to the process zone. The place of application will be left to the discretion of the practitioner. In order to establish a standard approach between the procedures performed, 18 gauge catheter will be used at the arm and the forearm areas, 20 gauge for the other regions. After the tourniquet is inserted, the procedure time will be calculated as seconds. In order for the successful vascular access to be considered successful, at least 5 ml of blood should be taken or at least 5 ml of saline fluid should be given. In all three approaches, if there is no success after 2 attempts, the 3rd and subsequent trials will be evaluated as rescue interventions and these interventions will be left to the discretion of the practitioner and this will be recorded observably (standard approach, usg, infra red light, central vascular, intraosseous approach, calling senior nurse, calling emergency medicine physician etc.). For all three approaches, the success of the first trial, the total duration of the procedure (in seconds), the total number of trials, and rescue method need will be recorded.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35030
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have previously described a history of difficult vascular access.
  • Patients who do not have palpable or visible veins after tourniquet placement or who have been referred to unusual locations due to the lack of appropriate veins in the upper extremity.
  • Patients who are expected to be hard to perform the procedure by the senior nurse.

Exclusion Criteria:

  • The patients who do not need vascular access.
  • Patients who do not give consent
  • Pregnant patients
  • Patients who are under 18 years old
  • Patients who require immediate intervention due to any life-threatening condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard technique group
In this group, peripheral intravenous catheter insertion will be performed routinely.
Active Comparator: Ultrasound group
In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.
Device: Ultrasound group
In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
Active Comparator: Near Infrared Device Group
In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.
Device: Near Infrared Device Group
In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Success in the First Attempt
Time Frame: 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
From the time of randomization until the time of the first successful attempt, up to 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time.
Time Frame: From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.
Time of the intravenous catheter placement procedure
From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.
Patients Who Need Rescue Methods
Time Frame: Up to 1 hour.
The method used as a rescue method when the primary method fails to achieve success.
Up to 1 hour.
Number of Attempts
Time Frame: 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.
From the time of randomization until the time of the successful attempt, up to 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Özge Can, MD, Ege University
  • Principal Investigator: İlhan Uz, MD, Ege University
  • Principal Investigator: Gülbin Konakçı, Asst. Prof., İzmir Demokrasi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-7/32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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