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| Name | Class |
|---|---|
| Official College of Nurses of Lleida | UNKNOWN |
| Department of Health, Generalitat de Catalunya (PERIS) | UNKNOWN |
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A study to evaluate a needle-free connector (a stopper) featuring anti-reflux technology (to prevent blood from flowing back) for catheters (polyurethane tubes inserted into a vein), with the aim of reducing complications associated with these devices: blockages, infections, pain, etc.
Introduction: Long peripheral venous catheters (PVCs) are a suitable alternative to short PVCs, midline catheters (MLCs) and central venous catheters (CVCs), particularly in patients with difficult intravenous access (DIVA), due to their characteristics: they are between 6 and 15 centimetres in length, have a gauge of 18 to 22 gauge (G), and do not extend beyond the axillary vein.
Hypothesis: The use of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) in long PVCs in adult inpatients with acute conditions reduces the number of catheter failures during the first seven days compared with a neutral-displacement needle-free connector without an anti-reflux valve.
Objective: To evaluate the efficacy of using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) following the insertion of long PVCs in adult inpatients in the acute phase of their illness during the first seven days.
Methodology: A clinical study involving two randomised groups will be conducted prior to catheter placement. The control group will receive treatment using a needle-free connector with neutral fluid displacement and without an anti-reflux valve (Microclave® Clear, Ref. 011-MC3302). The intervention group will receive treatment using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
Expected results: It is expected that the incidence of complications associated with long PVCs in hospitalised adult patients will be reduced following the standardised implementation of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) during the initial phase of treatment. Specifically, a reduction in the incidence of catheter obstructions and CRBSI is anticipated.
Clinical implication: The study will contribute to optimising decision-making regarding catheter maintenance and related therapeutic measures, with the aim of reducing the main complications associated with them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle-free connector without anti-reflux technology | Active Comparator | Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302). |
|
| Needle-free connector with anti-reflux technology | Experimental | Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle-free connector with neutral fluid displacement and without anti-reflux technology | Procedure | Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0. | Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®). | To determine the total number of partial and complete occlusions in long peripheral venous catheters in adult inpatients during the acute phase of illness within the first seven days after insertion of either a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™) or a neutral connector without this technology. |
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Inclusion Criteria:
Exclusion Criteria:
- Inability to place a long peripheral venous catheter in the upper limbs.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Padilla-Nula F PhD candidate, Nurse | Contact | + 34 973 24 81 00 | 8 4169 | FPADILLA@gencat.cat |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39183695 | Background | Krath J, Fredskilde J, Christensen SK, Baltsen CD, Valentin K, Offersen R, Juhl-Olsen P. The performance and complications of long peripheral venous catheters: A retrospective single-centre study. Acta Anaesthesiol Scand. 2024 Nov;68(10):1463-1470. doi: 10.1111/aas.14517. Epub 2024 Aug 26. | |
| 26209949 | Background |
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They will be available by the end of 2026.
DOI: 10.17632/jy54dx33pz.1
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A classic parallel-group design will be used, consisting of an intervention group and a control group. The intervention group will receive catheters fitted with a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139), whereas the control group will receive a needle-free connector with neutral fluid displacement but without anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
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Researchers will be responsible for catheter insertion and subsequent data collection; however, patients will be blinded to the type of needle-free connector used (with or without anti-reflux technology). In addition, the results will be evaluated by an independent researcher who is not involved in the data collection process.
| Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology | Procedure | Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC. |
|
| Long peripheral venous catheter | Device | Placement of a 20-gauge long PVC in an arm vein using the AST. |
|
| Ultrasound scanner | Other | All punctures will be performed under ultrasound guidance. |
|
| 7 days |
| Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26. |
| Background | U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Cancer Ther Eval Progr [Internet]. 2017;155. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf |
| 20619135 | Background | Schulz KF, Altman DG, Moher D; Consort Group. [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Zhong Xi Yi Jie He Xue Bao. 2010 Jul;8(7):604-12. doi: 10.3736/jcim20100702. Chinese. |
| Background | Valentino R, Farkas V. Maximizing the Midline [Internet]. AVA. 2015 [cited 2025 Jul 16]. p. 1. Available from: https://nexusmedical.com/wp-content/uploads/2021/04/nexus-medical-poster-25-valentino-farkas-maximizing-the-midline-new-york-methodist-hospital-2015-ava-national-conference.pdf |
| Background | ICU medical. Observational In-Vivo Evaluation of the NeutronTM Needlefree Catheter Patency Device and its Effects on Catheter Occlusions in a Home Care Setting [Internet]. icumed.com; 2011. p. 1-2. Available from: https://www.icumed.com/media/ddqd4cgy/p23-5809_neutron-catheter-patency-and-occlusions-home-care-setting_web.pdf |
| 40047605 | Background | Moureau N, Gorski L, Flynn J, Johnson K. A Systematic Review of Needleless Connector Function and Occlusion Outcomes: Evidence Leading the Way. J Infus Nurs. 2025 Mar-Apr 01;48(2):84-105. doi: 10.1097/NAN.0000000000000578. Epub 2025 Mar 6. |
| Background | Nexus medical. Nexus TKO® Technology [Internet]. nexusmedical.com. 2022 [cited 2025 Jul 16]. p. 1-10. Available from: https://nexusmedical.com/tko-technology/ |
| Background | ICU medical. ClaveTM NeutronTM: Anti-Reflux Neutral Displacement Needlefree Connector [Internet]. https://www.icumed.com/. 2025 [cited 2025 Jul 16]. p. 1-13. Available from: https://www.icumed.com/products/infusion-therapy/infusion-consumables/iv-connectors/clave-neutron/ |
| Background | Brodnik JE, Lieux SM, Serrano-Smith M, Bena JF, Siedlecki SL. PICC Line Occlusions: Implications and Opportunities for Medical-Surgical Nurses. MEDSURG Nurs [Internet]. 2023;32(5):305. Available from: https://www.jannettipublications.com/journal/470987/volume/474881/article/474947 |
| 40309318 | Background | Weber Y, Cohn-Schwartz D, Khamis S, Neuberger A, Berger G. Safety and efficacy of a new long peripheral catheter in hospitalized patients - a retrospective observational study. SAGE Open Med. 2025 Apr 29;13:20503121251337197. doi: 10.1177/20503121251337197. eCollection 2025. |
| 31647353 | Background | Gilardi E, Giannuzzi R, WoldeSellasie K, Piano A, Pittiruti M, Scoppettuolo G. Mini-midline in difficult intravenous access patients in emergency department: A prospective analysis. J Vasc Access. 2020 Jul;21(4):449-455. doi: 10.1177/1129729819883129. Epub 2019 Oct 24. |
| 36065094 | Background | Gilardi E, Grandi T, Giannuzzi R, Valletta F, Fugger S, Mazzaroppi S, Petrucci M, Piano A, Piccioni A, WoldeSellasie K, Sambuco F, Travaglino F. Long peripheral cannula in COVID-19 patients: 769 catheter days experience from a semi-intensive respiratory COVID unit. J Vasc Access. 2024 Mar;25(2):498-503. doi: 10.1177/11297298221115002. Epub 2022 Sep 5. |
| 40091028 | Background | Yuan M, Li J, Shao W, Xu C, Luo N, Wang H. Evaluating the impact train-the-trainer program in nurse training for mini-midline catheter insertion. BMC Med Educ. 2025 Mar 17;25(1):389. doi: 10.1186/s12909-025-06975-5. |
| 38944156 | Background | Fabiani A, Aversana N, Santoro M, Calandrino D, Liotta P, Sanson G. The longer the catheter, the lower the risk of complications: Results of the HERITAGE study comparing long peripheral and midline catheters. Am J Infect Control. 2024 Nov;52(11):1289-1295. doi: 10.1016/j.ajic.2024.06.019. Epub 2024 Jun 27. |
| 36898280 | Background | Fabiani A, Santoro M, Sanson G. The catheter-to-vein ratio at the tip level, not the catheter type, as a risk factor for a catheter failure. A retrospective comparative study of polyurethane midline and long peripheral catheters. Heart Lung. 2023 Jul-Aug;60:39-44. doi: 10.1016/j.hrtlng.2023.02.027. Epub 2023 Mar 8. |
| 30037560 | Background | Bahl A, Hang B, Brackney A, Joseph S, Karabon P, Mohammad A, Nnanabu I, Shotkin P. Standard long IV catheters versus extended dwell catheters: A randomized comparison of ultrasound-guided catheter survival. Am J Emerg Med. 2019 Apr;37(4):715-721. doi: 10.1016/j.ajem.2018.07.031. Epub 2018 Jul 19. |
| Background | Báez O. Clasificación del Midline: Mini-Midline, Midline y Midline Midclavicular [Internet]. Vygon España. 2024 [cited 2025 Jan 28]. p. 1-10. Available from: https://campusvygon.com/es/clasificacion-del-midline-mini-midline-midline-y-midline-midclavicular/ |
| 35856581 | Background | Barton A. The benefits of vascular access service teams. Br J Nurs. 2022 Jul 21;31(14):S3. doi: 10.12968/bjon.2022.31.14.S3. No abstract available. |
| 35856587 | Background | Morrow S, DeBoer E, Potter C, Gala S, Alsbrooks K. Vascular access teams: a global outlook on challenges, benefits, opportunities, and future perspectives. Br J Nurs. 2022 Jul 21;31(14):S26-S35. doi: 10.12968/bjon.2022.31.14.S26. |
| 33356810 | Background | Corcuera Martinez MI, Aldonza Torres M, Diez Revilla AM, Maali Centeno S, Maneru Oria A, Elizari Roncal I, Ibarra Marin B, Casado Del Olmo MI, Escobedo Romero R, Ferraz Torres M. Impact assessment following implementation of a vascular access team. J Vasc Access. 2022 Jan;23(1):135-144. doi: 10.1177/1129729820984284. Epub 2020 Dec 26. |
| 37716948 | Background | Ricou Rios L, Esposito Catala C, Pons Calsapeu A, Adroher Mas C, Andres Martinez I, Nuno Ruiz I, Castella Creus M, Castella Fabregas L, Garcia Quesada MJ, Estrada Cuxart O, Ara Del Rey J, Lopez Segui F. Implementation of a vascular access specialist team in a tertiary hospital: a cost-benefit analysis. Cost Eff Resour Alloc. 2023 Sep 16;21(1):67. doi: 10.1186/s12962-023-00464-6. |
| 38100201 | Background | Quinn M, Horowitz JK, Krein SL, Gaston A, Ullman A, Chopra V. The role of hospital-based vascular access teams and implications for patient safety: A multi-methods study. J Hosp Med. 2024 Jan;19(1):13-23. doi: 10.1002/jhm.13253. Epub 2023 Dec 15. |
| 35441751 | Background | Kleidon TM, Schults J, Paterson R, Rickard CM, Ullman AJ. Comparison of ultrasound-guided peripheral intravenous catheter insertion with landmark technique in paediatric patients: A systematic review and meta-analysis. J Paediatr Child Health. 2022 Jun;58(6):953-961. doi: 10.1111/jpc.15985. Epub 2022 Apr 20. |
| 35633065 | Background | Brescia F, Pittiruti M, Spencer TR, Dawson RB. The SIP protocol update: Eight strategies, incorporating Rapid Peripheral Vein Assessment (RaPeVA), to minimize complications associated with peripherally inserted central catheter insertion. J Vasc Access. 2024 Jan;25(1):5-13. doi: 10.1177/11297298221099838. Epub 2022 May 27. |
| 38211609 | Background | Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, Meyer B, Sarver MJ, Crickman R, Ong J, Clare S, Hagle ME. Infusion Therapy Standards of Practice, 9th Edition. J Infus Nurs. 2024 Jan-Feb 01;47(1S Suppl 1):S1-S285. doi: 10.1097/NAN.0000000000000532. No abstract available. |
| 26888253 | Background | Bodenham Chair A, Babu S, Bennett J, Binks R, Fee P, Fox B, Johnston AJ, Klein AA, Langton JA, Mclure H, Tighe SQ. Association of Anaesthetists of Great Britain and Ireland: Safe vascular access 2016. Anaesthesia. 2016 May;71(5):573-85. doi: 10.1111/anae.13360. Epub 2016 Feb 17. |
| Background | Registered Nurses'Association of Ontario. Best practice guidelines for Vascular Access [Internet]. Second edi. RNAO, INVESTEN-isciii, editors. International Affaurs & Best Practice Guidelines. Ontario; 2021. 1-167 p. Available from: https://rnao.ca/bpg/guidelines/vascular-access-second-edition. |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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