Innovative Device for Intravenous Administration

Safety Issues Clinical Trial

— SeringaDUO  

Official title:

Innovative Device for Intravenous Administration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04046770
• Other study ID #: SeringaDuo
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: November 2020

Study information

• Verified date: August 2019
• Source: Escola Superior de Enfermagem de Coimbra
• Contact: Pedro Parreira, PhD
• Phone: +351 239802850 / 239487200
• Email: parreira[@]esenfc.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter).

A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with 18 years or above, admitted to the orthopaedic department;

• Patients with the ability to fully communicate in Portuguese;

• Patients able to consent;

• Prescribed PIVC for intravenous therapeutic administration;

• PIVC expected to remain for at least 24 hours;

• PIVC inserted at the orthopaedic department;

• PIVC size 18 gauge (G) or 20 G;

• Anatomical insertion site in arm, forearm, or back of the hand;

• PIVC secured with a transparent, semi-permeable polyurethane film dressing.

Exclusion Criteria:

• - Patients with a known infectious disease;

• Patients with leucocytosis, defined as =1200 leukocytes/mm3;

• Patients with anaemia, with haemoglobin levels <13g/dl for men, and <12g/dl for women;

• Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;

• Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;

• Patients with body mass index below 16 kg/m2 or above 39 kg/m2;

• Anatomical insertion site in flexion areas (e.g. cubital fossa region) or lower members;

• Skin lesions at the insertion site (e.g. previous infiltration, dermatitis, burns) and skin alterations such as tattoos;

• Peripheral venous alterations resulting from previous hospital admissions.

Related Conditions & MeSH terms

• Medical Device
• Safety Issues

Intervention

Device:
• Drug administration and Flushing procedure using Double-Chamber Syringe
The new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device.
• Drug administration and Flushing procedure using Classic Syringe
To fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Escola Superior de Enfermagem de Coimbra	Centro Hospitalar e Universitário de Coimbra, E.P.E., Hospital de Braga, Hospital Distrital da Figueira da Foz, EPE

References & Publications (25)

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

Bishop L, Dougherty L, Bodenham A, Mansi J, Crowe P, Kibbler C, Shannon M, Treleaven J. Guidelines on the insertion and management of central venous access devices in adults. Int J Lab Hematol. 2007 Aug;29(4):261-78. Review. — View Citation

Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007 Feb;4(2):e61. Review. — View Citation

Braga LM, Parreira PM, Oliveira ASS, Mónico LDSM, Arreguy-Sena C, Henriques MA. Phlebitis and infiltration: vascular trauma associated with the peripheral venous catheter. Rev Lat Am Enfermagem. 2018;26:e3002. doi: 10.1590/1518-8345.2377.3002. Epub 2018 May 17. Portuguese, Spanish, English. — View Citation

Capdevila JA, Guembe M, Barberán J, de Alarcón A, Bouza E, Fariñas MC, Gálvez J, Goenaga MA, Gutiérrez F, Kestler M, Llinares P, Miró JM, Montejo M, Muñoz P, Rodríguez-Creixems M, Sousa D, Cuenca J, Mestres CA; on behalf the SEICAV, SEMI, SEQ and SECTCV Societies. 2016 Expert consensus document on prevention, diagnosis and treatment of short-term peripheral venous catheter-related infections in adult. Rev Esp Quimioter. 2016 Aug;29(4):230-8. Epub 2016 Aug 28. — View Citation

Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744. — View Citation

Dillon MF, Curran J, Martos R, Walsh C, Walsh J, Al-Azawi D, Lee CS, O'Shea D. Factors that affect longevity of intravenous cannulas: a prospective study. QJM. 2008 Sep;101(9):731-5. doi: 10.1093/qjmed/hcn078. Epub 2008 Jul 11. — View Citation

Dunda SE, Demir E, Mefful OJ, Grieb G, Bozkurt A, Pallua N. Management, clinical outcomes, and complications of acute cannula-related peripheral vein phlebitis of the upper extremity: A retrospective study. Phlebology. 2015 Jul;30(6):381-8. doi: 10.1177/0268355514537254. Epub 2014 May 20. — View Citation

Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014. — View Citation

Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14. Review. — View Citation

Guiffant G, Durussel JJ, Merckx J, Flaud P, Vigier JP, Mousset P. Flushing of intravascular access devices (IVADs) - efficacy of pulsed and continuous infusions. J Vasc Access. 2012 Jan-Mar;13(1):75-8. doi: 10.5301/JVA.2011.8487. — View Citation

Ho KH, Cheung DS. Guidelines on timing in replacing peripheral intravenous catheters. J Clin Nurs. 2012 Jun;21(11-12):1499-506. doi: 10.1111/j.1365-2702.2011.03974.x. Epub 2012 Feb 17. — View Citation

Keogh S, Flynn J, Marsh N, Higgins N, Davies K, Rickard CM. Nursing and midwifery practice for maintenance of vascular access device patency. A cross-sectional survey. Int J Nurs Stud. 2015 Nov;52(11):1678-85. doi: 10.1016/j.ijnurstu.2015.07.001. Epub 2015 Jul 11. — View Citation

Keogh S, Flynn J, Marsh N, Mihala G, Davies K, Rickard C. Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: a pilot, factorial randomised controlled trial in adult medical-surgical hospital patients. Trials. 2016 Jul 26;17(1):348. doi: 10.1186/s13063-016-1470-6. — View Citation

Loveday HP, Wilson JA, Pratt RJ, Golsorkhi M, Tingle A, Bak A, Browne J, Prieto J, Wilcox M, UK Department of Health. epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect. 2014 Jan;86 Suppl 1:S1-70. doi: 10.1016/S0195-6701(13)60012-2. — View Citation

Marsh N, Webster J, Flynn J, Mihala G, Hewer B, Fraser J, Rickard CM. Securement methods for peripheral venous catheters to prevent failure: a randomised controlled pilot trial. J Vasc Access. 2015 May-Jun;16(3):237-44. doi: 10.5301/jva.5000348. Epub 2015 Feb 4. — 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

Martínez JA, Piazuelo M, Almela M, Blecua P, Gallardo R, Rodríguez S, Escalante Z, Robau M, Trilla A. Evaluation of add-on devices for the prevention of phlebitis and other complications associated with the use of peripheral catheters in hospitalised adults: a randomised controlled study. J Hosp Infect. 2009 Oct;73(2):135-42. doi: 10.1016/j.jhin.2009.06.031. Epub 2009 Aug 27. — View Citation

Ngo A, Murphy S. A theory-based intervention to improve nurses' knowledge, self-efficacy, and skills to reduce PICC occlusion. J Infus Nurs. 2005 May-Jun;28(3):173-81. — View Citation

O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. — View Citation

Park SM, Jeong IS, Kim KL, Park KJ, Jung MJ, Jun SS. The Effect of Intravenous Infiltration Management Program for Hospitalized Children. J Pediatr Nurs. 2016 Mar-Apr;31(2):172-8. doi: 10.1016/j.pedn.2015.10.013. Epub 2015 Nov 19. — View Citation

Rickard CM, McCann D, Munnings J, McGrail MR. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial. BMC Med. 2010 Sep 10;8:53. doi: 10.1186/1741-7015-8-53. — View Citation

Rickard CM, Webster J, Wallis MC, Marsh N, McGrail MR, French V, Foster L, Gallagher P, Gowardman JR, Zhang L, McClymont A, Whitby M. Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial. Lancet. 2012 Sep 22;380(9847):1066-74. doi: 10.1016/S0140-6736(12)61082-4. — View Citation

Tuffaha HW, Rickard CM, Webster J, Marsh N, Gordon L, Wallis M, Scuffham PA. Cost-effectiveness analysis of clinically indicated versus routine replacement of peripheral intravenous catheters. Appl Health Econ Health Policy. 2014 Feb;12(1):51-8. doi: 10.1007/s40258-013-0077-2. — View Citation

Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter-related complications: phlebitis	Phlebitis (the irritation or inflammation to the vein wall, associated with warmth, tenderness, erythema or palpable cord) is the most frequent PIVC-related complication, which may have mechanical, chemical, or bacterial causes	This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.
Primary	Catheter-related complications: infiltration	Moreover, the extravasation or infiltration of fluids may be responsible for local oedema due to the pervasion of intravenous fluid into the interstitial compartment, causing inflammation of the tissue around the catheter site.	This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Primary	Catheter-related complications: occlusion	Occlusion is defined as any circumstance in which the Peripheral Intravenous Catheter (PIVC) does not enable to flush the catheter or infuse fluids/medications and it is a clinical sign of catheter malfunctioning	This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Secondary	Other catheter-related removal causes not related with the primary outcomes	The secondary outcomes involve other reasons for catheter removal (e.g. accidental dislodgment), maintenance time of the catheter, number of syringes and catheters used during the intravenous treatment, catheterization attempts, nurses' perception about risk and safety, as well as the satisfaction of the participant.	This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.