Ultrasound-guided Subclavian Vein Catheterisation with a Needle Guide (ELUSIVE): Protocol for a Randomised Controlled Study

Overview

Journal BMJ Open

Specialty General Medicine

Date 2023 Dec 19

PMID 38114277

Authors

Leila Naddi

Ola Borgquist

Maria Adrian

Bjorn P Bark

Thomas Kander

Affiliations

Soon will be listed here.

Abstract

Introduction: Central venous catheters are indispensable in modern healthcare. Unfortunately, they are accompanied by minor as well as major complications, leading to increased morbidity, mortality and costs. Immediate insertion-related complications (mechanical complications) have decreased due to the implementation of real-time ultrasound guidance, but they still occur and additional efforts to enhance patient safety are warranted. This study aims to investigate whether the use of a needle guide mounted on the ultrasound probe in subclavian catheterisations may decrease the number of catheterisations with >1 skin puncture (primary outcome).

Methods And Analysis: This is an investigator-initiated, non-commercial, randomised, controlled, parallel-group study conducted at Skåne University Hospital, Lund, Sweden. Adults (≥18 years) with a clinical indication for a subclavian central venous catheter and the ability to give written informed consent will be eligible for inclusion. Exclusion criteria include subclavian catheterisation deemed unsuitable based on the preprocedural ultrasound examination. Patients will be randomised to catheterisation by certified operators using a microconvex probe (long-axis, in-plane technique) with (n=150) or without (n=150) a needle guide. The ultrasound imaging from the procedures will be recorded and assessed by two reviewers individually. The assessors will be blinded for group affiliation. Secondary outcomes include the total number of skin punctures, mechanical complications, time to successful venous puncture, number of failed catheterisations and operator satisfaction with the needle guide at the end of the study period.Recruitment started on 8 November 2022 and will continue until the sample size is achieved.

Ethics And Dissemination: This study was approved by the Swedish Ethical Review Authority (#2022-04073-01) and the Swedish Medical Products Agency (#5.1-2022-52130; CIV-21-12-038367). The findings will be submitted to an international peer-reviewed journal.

Trial Registration Number: NCT05513378, clinicaltrials.gov.

References

Zawadka M, La Via L, Wong A, Olusanya O, Muscara L, Continella C . Real-Time Ultrasound Guidance as Compared With Landmark Technique for Subclavian Central Venous Cannulation: A Systematic Review and Meta-Analysis With Trial Sequential Analysis. Crit Care Med. 2023; 51(5):642-652. DOI: 10.1097/CCM.0000000000005819. View

Ives C, Moe D, Inaba K, Castelo Branco B, Lam L, Talving P . Ten years of mechanical complications of central venous catheterization in trauma patients. Am Surg. 2012; 78(5):545-9. DOI: 10.1177/000313481207800535. View

Calvache J, Rodriguez M, Trochez A, Klimek M, Stolker R, Lesaffre E . Incidence of Mechanical Complications of Central Venous Catheterization Using Landmark Technique: Do Not Try More Than 3 Times. J Intensive Care Med. 2014; 31(6):397-402. DOI: 10.1177/0885066614541407. View

Kusminsky R . Complications of central venous catheterization. J Am Coll Surg. 2007; 204(4):681-96. DOI: 10.1016/j.jamcollsurg.2007.01.039. View

Mao Q, He H, Lu Y, Hu Y, Wang Z, Gan M . A new method for facilitating ultrasound-guided in-plane cannulation of the subclavian vein: a randomized clinical trial. Sci Rep. 2021; 11(1):9605. PMC: 8099870. DOI: 10.1038/s41598-021-88798-0. View

Brass P, Hellmich M, Kolodziej L, Schick G, Smith A . Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015; 1:CD011447. PMC: 6516998. DOI: 10.1002/14651858.CD011447. View

Parienti J, Mongardon N, Megarbane B, Mira J, Kalfon P, Gros A . Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015; 373(13):1220-9. DOI: 10.1056/NEJMoa1500964. View

Maecken T, Heite L, Wolf B, Zahn P, Litz R . Ultrasound-guided catheterisation of the subclavian vein: freehand vs needle-guided technique. Anaesthesia. 2015; 70(11):1242-9. DOI: 10.1111/anae.13187. View

Lathey R, Jackson R, Bodenham A, Harper D, Patle V . A multicentre snapshot study of the incidence of serious procedural complications secondary to central venous catheterisation. Anaesthesia. 2016; 72(3):328-334. DOI: 10.1111/anae.13774. View

10.

Bodenham Chair A, Babu S, Bennett J, Binks R, Fee P, Fox B . Association of Anaesthetists of Great Britain and Ireland: Safe vascular access 2016. Anaesthesia. 2016; 71(5):573-85. PMC: 5067617. DOI: 10.1111/anae.13360. View

11.

Donati A, Damiani E, Adrario E, Romano R, Pelaia P . Pain and discomfort management during central venous catheter insertion. Indian J Crit Care Med. 2014; 18(7):417-8. PMC: 4118504. DOI: 10.4103/0972-5229.136066. View

12.

McGee D, Gould M . Preventing complications of central venous catheterization. N Engl J Med. 2003; 348(12):1123-33. DOI: 10.1056/NEJMra011883. View

13.

Adrian M, Borgquist O, Kroger T, Linne E, Bentzer P, Spangfors M . Mechanical complications after central venous catheterisation in the ultrasound-guided era: a prospective multicentre cohort study. Br J Anaesth. 2022; 129(6):843-850. DOI: 10.1016/j.bja.2022.08.036. View

14.

Sobolev M, Shiloh A, Di Biase L, Slovut D . Ultrasound-guided cannulation of the femoral vein in electrophysiological procedures: a systematic review and meta-analysis. Europace. 2016; 19(5):850-855. DOI: 10.1093/europace/euw113. View

15.

Bjorkander M, Bentzer P, Schott U, Broman M, Kander T . Mechanical complications of central venous catheter insertions: A retrospective multicenter study of incidence and risks. Acta Anaesthesiol Scand. 2018; 63(1):61-68. DOI: 10.1111/aas.13214. View

16.

Lamperti M, Bodenham A, Pittiruti M, Blaivas M, Augoustides J, Elbarbary M . International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med. 2012; 38(7):1105-17. DOI: 10.1007/s00134-012-2597-x. View

17.

Eisen L, Narasimhan M, Berger J, Mayo P, Rosen M, Schneider R . Mechanical complications of central venous catheters. J Intensive Care Med. 2006; 21(1):40-6. DOI: 10.1177/0885066605280884. View

18.

. Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2019; 132(1):8-43. DOI: 10.1097/ALN.0000000000002864. View

19.

Chen Y, Bao H, Hu T, He Z, Wen B, Liu F . Comparison of comfort and complications of Implantable Venous Access Port (IVAP) with ultrasound guided Internal Jugular Vein (IJV) and Axillary Vein/Subclavian Vein (AxV/SCV) puncture in breast cancer patients: a randomized controlled study. BMC Cancer. 2022; 22(1):248. PMC: 8898472. DOI: 10.1186/s12885-022-09228-6. View

20.

Shafique M, Akhtar S, Mahnoor M, Hussain M . Hemodialysis Internal jugular vein versus Subclavian vein Catheters: Complications, patients' comfort, tolerance and cost-effectiveness. Pak J Med Sci. 2019; 35(1):124-128. PMC: 6408634. DOI: 10.12669/pjms.35.1.249. View