Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections (TecPrevInf)

February 5, 2021 updated by: Anabela Salgueiro-Oliveira, Escola Superior de Enfermagem de Coimbra

The insertion of peripheral vascular catheters (PVCs) is the most often invasive procedure performed in hospital settings. During hospitalization, the majority of patients need to have a PVC inserted. These devices are not risk-free, affecting patients' safety and well-being. In clinical settings, health professionals must deal with difficult venous accesses due to the patient's age, physical characteristics, clinical status, and medication, which hinder the PVC insertion. When veins are not visible or palpable, this may lead to successive puncture attempts, causing pain to the patient and discomfort to the nurse, which results in increased costs.

Guidelines state that puncture should be attempted only twice per professional, to a maximum of four attempts; against this recommendation and due to the patient's therapeutic needs and clinical situation, health professionals attempt to puncture multiple times in a single scenario. In this regard, health professionals should consider using specific technologies that help to select the vein and reduce the number of puncture attempts and catheter-related mechanical complications. Taking into account the multiplicity of existing technologies in the international market that assist health professionals in peripheral venous catheterization, ultrasound and infrared devices emerge in the literature as two of the most commonly used during this procedure.

These technologies were developed with the purpose of improving peripheral intravenous catheterization success rate and thus reducing the number and extent of the negative effects of multiple or unsuccessful attempts, with the additional purpose of avoiding the frustrations of health professionals in these scenarios. However, such technologies are still underused in clinical practice, since health professionals are not familiar with the use of these devices. Moreover, the costs associated with their purchase and maintenance may be considered as excessive in relation to the traditional method.

The project investigators aim to determine whether the use of either ultrasound or near-infrared vascular imaging will significantly improve the success rate of peripheral intravenous catheterization in adults on first attempt by nurses compared with the standard approach, reduce immediate related complications and improve patient and provider satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who require peripheral intravenous catheterization as part of routine care;
  • Participants whose primary nurse agrees to participate in the study;
  • Participants who are able to give written assent or oral assent.

Exclusion Criteria:

  • Confused and/or disoriented participants;
  • Participants who are unable to communicate orally and/or in writing.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound imaging
Ultrasonography offers visual information about the size and depth of blood vessels, potentially facilitating intravenous placement of the needle in real time.
Device: Ultrasound
Ultrasound allows viewing veins and surrounding anatomical structures, making it easier to perform the placement of a cannula into a peripherally located vein in real time. This process allows the cannulation of veins that are unable to be visualised or palpated.
Experimental: Near-infrared imaging
Near-infrared imaging devices project near-infrared light onto the skin, which is absorbed by deoxygenated hemoglobin. The invisible image of the underlying vascular pattern is captured by the device, processed and projected, in real time, back onto the patient's skin using visible green light. This technology allows hands-free visualization of a vascular map to guide catheter placement.
Device: Near Infrared Light
Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful intravenous catheterization on the first attempt
Time Frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months., assessed up to 6 months
Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.
This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months., assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts to successful intravenous catheter placement
Time Frame: Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Time to successful placement (in minutes)
Time Frame: From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Patient satisfaction
Time Frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Evaluated through a self-report scale where the participant identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.
This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Nurse satisfaction
Time Frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Evaluated through a self-report scale where the nurse identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.
This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Immediate Complications
Time Frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Evaluated through a self-report scale where the nurse identifies a set of indicators associated to the occurrence of immediate complications during the procedure (extravasation, puncture of proximal anatomical structures, hematoma, etc.).
This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months.
Patient anxiety (State-Trait Anxiety Inventory)
Time Frame: Anxiety will be assessed about ten minutes before and ten minutes after the intervention. This outcome will be assessed through study completion, an average of 6 months.
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983). It can be used in clinical settings to diagnose anxiety. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.
Anxiety will be assessed about ten minutes before and ten minutes after the intervention. This outcome will be assessed through study completion, an average of 6 months.

Collaborators and Investigators

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

Sponsor

Escola Superior de Enfermagem de Coimbra

Collaborators

Centro Hospitalar e Universitário de Coimbra, E.P.E.
Escola Superior de Tecnologia da Saúde de Coimbra
Associação Portuguesa de Acessos Vasculares

Investigators

  • Principal Investigator: Anabela Salgueiro-Oliveira, Ph.D, Assistant Professor

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)

October 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TecPrevInf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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