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

Primary Purpose

Catheterization, Peripheral

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Ultrasound
Near Infrared Light
Sponsored by
Escola Superior de Enfermagem de Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catheterization, Peripheral focused on measuring Catheterization, Peripheral, Ultrasound, Near Infrared Light

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Hospitalar e Universitário de Coimbra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound imaging

Near-infrared imaging

Arm Description

Ultrasonography offers visual information about the size and depth of blood vessels, potentially facilitating intravenous placement of the needle in real time.

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.

Outcomes

Primary Outcome Measures

Successful intravenous catheterization on the first attempt
Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.

Secondary Outcome Measures

Number of attempts to successful intravenous catheter placement
Time to successful placement (in minutes)
Patient satisfaction
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.
Nurse satisfaction
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.
Immediate Complications
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.).
Patient anxiety (State-Trait Anxiety Inventory)
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.

Full Information

First Posted
May 9, 2018
Last Updated
February 5, 2021
Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Centro Hospitalar e Universitário de Coimbra, E.P.E., Associação Portuguesa de Acessos Vasculares, Escola Superior de Tecnologia da Saúde de Coimbra
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1. Study Identification

Unique Protocol Identification Number
NCT03563703
Brief Title
Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections
Acronym
TecPrevInf
Official Title
Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Centro Hospitalar e Universitário de Coimbra, E.P.E., Associação Portuguesa de Acessos Vasculares, Escola Superior de Tecnologia da Saúde de Coimbra

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheterization, Peripheral
Keywords
Catheterization, Peripheral, Ultrasound, Near Infrared Light

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Once eligibility, informed consent and assent are confirmed, participants will be randomly assigned, in the appropriate age stratum, to 1 of 2 groups: peripheral intravenous catheterization with the standard approach or with the help of either ultrasound or near-infrared vascular imaging. Randomization will be achieved with the use of an online, computer-generated program.
Masking
InvestigatorOutcomes Assessor
Masking Description
Because of the physical nature of the interventions, it will not be possible to conceal the group allocation from the nurses or trial participants.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound imaging
Arm Type
Experimental
Arm Description
Ultrasonography offers visual information about the size and depth of blood vessels, potentially facilitating intravenous placement of the needle in real time.
Arm Title
Near-infrared imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Near Infrared Light
Intervention Description
Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.
Primary Outcome Measure Information:
Title
Successful intravenous catheterization on the first attempt
Description
Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.
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
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
Patient satisfaction
Description
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.
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.
Title
Nurse satisfaction
Description
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.
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.
Title
Immediate Complications
Description
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.).
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.
Title
Patient anxiety (State-Trait Anxiety Inventory)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabela Salgueiro-Oliveira, Ph.D
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers.
Citations:
PubMed Identifier
26068958
Citation
Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database Syst Rev. 2015 Jun 12;(6):CD011070. doi: 10.1002/14651858.CD011070.pub2.
Results Reference
background
PubMed Identifier
15007740
Citation
Grune F, Schrappe M, Basten J, Wenchel HM, Tual E, Stutzer H; Cologne Quality Control Network. Phlebitis rate and time kinetics of short peripheral intravenous catheters. Infection. 2004 Feb;32(1):30-2. doi: 10.1007/s15010-004-1037-4.
Results Reference
background
PubMed Identifier
17719678
Citation
Pujol M, Hornero A, Saballs M, Argerich MJ, Verdaguer R, Cisnal M, Pena C, Ariza J, Gudiol F. Clinical epidemiology and outcomes of peripheral venous catheter-related bloodstream infections at a university-affiliated hospital. J Hosp Infect. 2007 Sep;67(1):22-9. doi: 10.1016/j.jhin.2007.06.017. Epub 2007 Aug 27.
Results Reference
background
PubMed Identifier
25525365
Citation
Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
Results Reference
background
PubMed Identifier
24684163
Citation
Cicolini G, Manzoli L, Simonetti V, Flacco ME, Comparcini D, Capasso L, Di Baldassarre A, Eltaji Elfarouki G. Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi-centre prospective study. J Adv Nurs. 2014 Nov;70(11):2539-49. doi: 10.1111/jan.12403. Epub 2014 Mar 31.
Results Reference
background
PubMed Identifier
23035825
Citation
Dorniak-Wall T, Rudaks L, Solanki NS, Greenwood J. Safe and correct use of peripheral intravenous devices. ANZ J Surg. 2013 Oct;83(10):764-8. doi: 10.1111/j.1445-2197.2012.06281.x. Epub 2012 Oct 4.
Results Reference
background
PubMed Identifier
25175514
Citation
Ismailoglu EG, Zaybak A, Akarca FK, Kiyan S. The effect of the use of ultrasound in the success of peripheral venous catheterisation. Int Emerg Nurs. 2015 Apr;23(2):89-93. doi: 10.1016/j.ienj.2014.07.010. Epub 2014 Aug 15.
Results Reference
background
PubMed Identifier
27311149
Citation
Partovi-Deilami K, Nielsen JK, Moller AM, Nesheim SS, Jorgensen VL. Effect of Ultrasound-Guided Placement of Difficult-to-Place Peripheral Venous Catheters: A Prospective Study of a Training Program for Nurse Anesthetists. AANA J. 2016 Apr;84(2):86-92.
Results Reference
background
PubMed Identifier
27785562
Citation
Park JM, Kim MJ, Yim HW, Lee WC, Jeong H, Kim NJ. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1975-1988. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.
Results Reference
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Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections

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