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

Catheterization, Peripheral Clinical Trial

— TecPrevInf  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563703
• Other study ID #: TecPrevInf
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2021
• Source: Escola Superior de Enfermagem de Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheterization, Peripheral
• Infection

Intervention

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

Locations

Country	Name	City	State
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra

Sponsors (4)

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

Country where clinical trial is conducted

Portugal, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

Grüne F, Schrappe M, Basten J, Wenchel HM, Tual E, Stützer H; Cologne Quality Control Network. Phlebitis rate and time kinetics of short peripheral intravenous catheters. Infection. 2004 Feb;32(1):30-2. — View 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. — View 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. Review. — View 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. Epub 2016 Oct 26. Review. — View 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. — View Citation

Pujol M, Hornero A, Saballs M, Argerich MJ, Verdaguer R, Cisnal M, Peña 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. Epub 2007 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Number of attempts to successful intravenous catheter placement		Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Secondary	Time to successful placement (in minutes)		From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Secondary	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.	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.
Secondary	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.	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.
Secondary	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.).	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.
Secondary	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.	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.