Developing a device model for a safe and effective method in catheter fixation: An experimental study

Alev Atalay; Lara Özbal; Vusala Mirza; Aslihan Esra Yüksel; Can Eyigör

doi:10.19161/etd.1795301

TR EN

Kateter sabitlemesinde güvenli ve etkin bir yöntem için cihaz modeli geliştirilmesi: Deneysel bir çalışma

Öz

Amaç: Günümüzde kullanılan kalıcı kateter sabitleme yöntemleri epidural kateterin yer değiştirmesine veya dışarı çıkmasına neden olabilmektedir. Bu durum, kateter göçü, yetersiz analjezi ve istenmeyen spinal blok gibi riskler taşır. Bu deneysel çalışmada, tarafımızca geliştirilen yeni bir sabitleme cihazı ile epidural kateter sabitlemesinde kullanılan geleneksel sütür yöntemi karşılaştırılmıştır. Gereç ve Yöntem: Ege Üniversitesi Teknopark CND ARGE tarafından geliştirilen Epilock® cihazının prototipi, Polilaktik Asit Termoplastik Polimer (PLA+) kullanılarak üç boyutlu yazıcıda üretilmiştir. Etik kurul onayı sonrasında, 10 Sprague Dawley sıçanı (5 dişi, 5 erkek) anestezi altında rastgele iki gruba ayrılmıştır. Kontrol grubunda (n=5) epidural kateterler, ipek sütürlerle (20 düğüm) derinin 11 cm altına sabitlenmiştir. Deney grubunda (n=5) ise kateterler Epilock® cihazı ile sabitlenmiştir. Kateter sabitleme süresi kaydedilmiş, kateter stabilitesi ve enfeksiyon açısından sıçanlar 7 gün boyunca izlenmiştir. Bulgular: Kontrol grubunda ortalama kateter sabitleme süresi 258 ± 250 saniye iken, deney grubunda 175 ± 150 saniye bulunmuştur. Epilock® cihazının kateter sabitleme süresini istatistiksel olarak anlamlı şekilde azalttığı gösterilmiştir (p=0,032). Kateter kalış süreleri karşılaştırıldığında, deney grubunda kateterler ilk günde anlamlı derecede daha uzun süre yerinde kalmıştır (p=0,048). Ancak ikinci günde anlamlı fark saptanmamıştır (p=1,000). Sonuç: Epilock® cihazı, geleneksel sütür yöntemine kıyasla daha kısa işlem süresi ve daha iyi erken dönem kateter retansiyonu sağlamıştır. Bu bulgular, özellikle pozisyon vermede zorluk yaşayan hastalarda konforun artırılmasına katkı sağlayabilir. Güvenli ve pratik bir alternatif olarak öne çıkan cihazın, gerekli geliştirmeler ve geniş kapsamlı klinik çalışmalarla rutin kullanımda önemli bir seçenek olabileceği düşünülmektedir.

Anahtar Kelimeler

Developing a device model for a safe and effective method in catheter fixation: An experimental study

Abstract

Aim: Current permanent catheter fixation techniques may lead to epidural catheter dislodgement or extrusion, resulting in risks such as catheter migration, inadequate analgesia, and unintended spinal block. This study aimed to compare a newly developed fixation device with the conventional suture method used for epidural catheter fixation. Materials and Methods: The Epilock® device, developed at Ege University Technopark CND ARGE, was manufactured using Polylactic Acid Thermoplastic Polymer (PLA+) material via a 3D printer. After obtaining ethical approval, 10 Sprague Dawley rats (5 males, 5 females) were anesthetized and randomly allocated into two groups. In the Control Group (n=5), epidural catheters were fixed 11 cm beneath the skin with silk sutures (20 knots). In the Experimental Group (n=5), catheters were secured using the Epilock® device. Fixation time was recorded, and the rats were monitored for catheter stability and infection for 7 days. Results: In the Control Group (n=5), the mean catheter fixation time was 258 ±250 seconds, while in the Experimental Group (n=5) it was 175 ±150 seconds. The Epilock® device significantly reduced fixation time compared the Control Group (p=0.032). Catheters remained significantly longer in place in the Experimental Group on the first day (p=0.048), whereas no significant difference was found on the second day (p=1.000). Conclusion: The Epilock® device provided a shorter procedure time and improved initial catheter retention compared with conventional suturing. These findings suggest it may enhance patient comfort, especially for those with positioning difficulties, and has the potential to be a valuable option in routine practice with further development and larger studies.

Keywords

Supporting Institution

This experimental study was supported by CND R&D, operating within Ege University Technopark

Ethical Statement

This study was approved by the Ege University Local Ethics Committee for Animal Experiments (Document Number: 2025-025, dated June 25, 2025). All methods were conducted in accordance with relevant guidelines and regulations. The study was carried out in compliance with the principles outlined in the Declaration of Helsinki (1964).

References

Tripathi M, Pandey M. Epidural catheter fixation: subcutaneous tunnelling with a loop to prevent displacement. Anaesthesia. 2000 Nov;55(11):1113–6.
McLeod G, Davies H, Munnoch N, Bannister J, MacRae W. Postoperative pain relief using thoracic epidural analgesia: outstanding success and disappointing failures. Anaesthesia. 2001 Jan;56(1):75–81.
Königsrainer I, Bredanger S, Drewel-Frohnmeyer R, Vonthein R, Krueger WA, Königsrainer A, et al. Audit of motor weakness and premature catheter dislodgement after epidural analgesia in major abdominal surgery. Anaesthesia. 2009 Jan;64(1):27–31.
van Kassel MN, Hermanides J, Lirk P, Hollmann MW. Prevention of Epidural Catheter Migration and Inflammation by Tunneling: A Systematic Review and Meta-Analysis. J Clin Med. 2025 Aug 15;14(16):5788.
Bomberg H, Kubulus C, Herberger S, Wagenpfeil S, Kessler P, Steinfeldt T, et al. Tunnelling of thoracic epidural catheters is associated with fewer catheter-related infections: a retrospective registry analysis. Br J Anaesth. 2016 Apr;116(4):546–53.
Gautam S, Agarwal A, Das PK, Khuba S, Kumar S. Prevention of epidural catheter migration: a comparative evaluation of two tunneling techniques. Korean J Anesthesiol. 2020 July 16;74(1):59–64.
Su J, Soliz JM, Popat KU, Gebhardt R. Complications of Postoperative Epidural Analgesia For Oncologic Surgery: A Review of 18,895 Cases. Clin J Pain. 2019 July;35(7):589–93.
Bishton IM, Martin PH, Vernon JM, Liu WH. Factors influencing epidural catheter migration. Anaesthesia. 1992 July;47(7):610–2.

Details

Primary Language

English

Subjects

Anaesthesiology

Journal Section

Research Article

Authors

Alev Atalay ^*
0000-0003-3695-2866
Türkiye

Lara Özbal
0009-0009-0018-7358
Türkiye

Vusala Mirza
0009-0006-4026-2963
Azerbaijan

Aslihan Esra Yüksel
0000-0003-2665-3467
Türkiye

Can Eyigör
0000-0002-7991-8564
Türkiye

Publication Date

March 9, 2026

Submission Date

October 7, 2025

Acceptance Date

October 27, 2025

Published in Issue

Year 2026 Volume: 65 Number: 1

DOI

https://doi.org/10.19161/etd.1795301

IZ

https://izlik.org/JA67WL73ZR

Cite

RIS / Bibtex

Vancouver

1.Alev Atalay, Lara Özbal, Vusala Mirza, Aslihan Esra Yüksel, Can Eyigör. Developing a device model for a safe and effective method in catheter fixation: An experimental study. EJM. 2026 Mar. 1;65(1):49-54. doi:10.19161/etd.1795301