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Completed

NCT Number: NCT03563703

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

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.

Near Infrared Light

Device

Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.).

  6. 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.

Sponsors and collaborators

Lead sponsor

Escola Superior de Enfermagem de Coimbra

Other

Collaborators

  • Associação Portuguesa de Acessos Vasculares
  • Escola Superior de Tecnologia da Saúde de Coimbra
  • Unidade Local de Saúde de Coimbra, EPE

Registry information

Acronym: TecPrevInf

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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