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

NCT ID: NCT03563703

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Catheterization, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Because of the physical nature of the interventions, it will not be possible to conceal the group allocation from the nurses or trial participants.

Study Groups

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Ultrasound imaging

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

Group Type EXPERIMENTAL

Ultrasound

Intervention Type 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 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.

Group Type EXPERIMENTAL

Near Infrared Light

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role collaborator

Associação Portuguesa de Acessos Vasculares

UNKNOWN

Sponsor Role collaborator

Escola Superior de Tecnologia da Saúde de Coimbra

OTHER

Sponsor Role collaborator

Escola Superior de Enfermagem de Coimbra

OTHER

Sponsor Role lead

Responsible Party

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Anabela Salgueiro-Oliveira

Ph.D, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anabela Salgueiro-Oliveira, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Site Status

Countries

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Portugal

References

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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;2015(6):CD011070. doi: 10.1002/14651858.CD011070.pub2.

Reference Type BACKGROUND
PMID: 26068958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15007740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17719678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25525365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24684163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23035825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25175514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27311149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27785562 (View on PubMed)

Other Identifiers

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TecPrevInf

Identifier Type: -

Identifier Source: org_study_id

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