Skin Glue Versus Suture for Securing Radial Arterial Lines

NCT06589284 | Completed FDA Device

• 1 other identifier: 2022078
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Prior investigators have evaluated the use of 2-octyl cyanoacrylate (glue) as a method to secure a variety of venous catheters including central/peripheral lines. There is a paucity of research evaluating the use of glue for arterial catheters. The investigators conducted a pilot study to test the null hypothesis that there would be no difference in failure rates between radial arterial lines (r-a-line) secured with glue vs. suture.

Conditions

Arterial Catheters; Catheter Related Complication

Keywords

2-octyl cyanoacrylate; Central lines; Peripheral lines; Glue; Suture; Chlorhexidine gluconate dressing

Outcome Measures

Primary Outcomes (2)

• Length of time which the catheter remained in place

  Primary outcomes measured were length of time of which the catheter remained in place and causes of premature failure, if it occurred.

  12 months

• Cause of premature failure (if occurred)

  Primary outcomes measured were length of time of which the catheter remained in place and causes of premature failure, if it occurred.

  12 months

Secondary Outcomes (2)

• Evaluation of patient demographics for line failure

  12 months

• Evaluation of line placement for line failure

  12 months

Study Arms (2)

Silk 0-0 suture covered by chlorhexidine gluconate dressing

OTHER

The provider will be asked to use standard straight suturing technique followed by a tegaderm dressing for securing the radial arterial catheter.

Procedure: Silk 0-0 suture covered by chlorhexidine gluconate dressing

2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing

OTHER

The provider will be asked to use skin glue in a standardized fashion followed by a tegaderm dressing for securing the radial arterial catheter.

Procedure: 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing

Interventions

Silk 0-0 suture covered by chlorhexidine gluconate dressing PROCEDURE

The specific intervention will be securing radial arterial catheters with either skin adhesive or suture material. Both are largely accepted to be standard of care but to date there is a paucity of literature directly comparing the two for radial arterial lines. During the intervention the placement of radial arterial catheters will be done via standard sterile procedure and using seldinger technique which involves using a guidewire to slide the arterial catheter into the radial artery. After the catheter is placed, it will be secure with either straight suture with a cutting needle or via skin adhesive. Following securement, the area will be cleaned and a Tegaderm dressing with biopatch will be placed over the catheter. Data will be collected immediately after the procedure including length of procedure and complications as well as via chart review to determine the length of time the catheter was in place and evidence of premature failure.

Silk 0-0 suture covered by chlorhexidine gluconate dressing

2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing PROCEDURE

The specific intervention will be securing radial arterial catheters with either skin adhesive or suture material. Both are largely accepted to be standard of care but to date there is a paucity of literature directly comparing the two for radial arterial lines. During the intervention the placement of radial arterial catheters will be done via standard sterile procedure and using seldinger technique which involves using a guidewire to slide the arterial catheter into the radial artery. After the catheter is placed, it will be secure with either straight suture with a cutting needle or via skin adhesive. Following securement, the area will be cleaned and a Tegaderm dressing with biopatch will be placed over the catheter. Data will be collected immediately after the procedure including length of procedure and complications as well as via chart review to determine the length of time the catheter was in place and evidence of premature failure.

2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• Require invasive blood pressure monitoring via radial arterial catheter

You may not qualify if:

• Under 18 years of age
• Pregnant

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Spohn Hospital Corpus Christi - Shoreline

Corpus Christi, Texas, 78404, United States

Location

Related Publications (12)

• Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.

  PMID: 12133178 BACKGROUND

• Simonova G, Rickard CM, Dunster KR, Smyth DJ, McMillan D, Fraser JF. Cyanoacrylate tissue adhesives - effective securement technique for intravascular catheters: in vitro testing of safety and feasibility. Anaesth Intensive Care. 2012 May;40(3):460-6. doi: 10.1177/0310057X1204000311.

  PMID: 22577911 BACKGROUND

• Wilkinson JN, Sheikh N, Jayamaha J. Tissue adhesive as an alternative to sutures for securing central venous catheters. Anaesthesia. 2007 Sep;62(9):969-70. doi: 10.1111/j.1365-2044.2007.05240.x. No abstract available.

  PMID: 17697235 BACKGROUND

• Auyong DB, Cantor DA, Green C, Hanson NA. The Effect of Fixation Technique on Continuous Interscalene Nerve Block Catheter Success: A Randomized, Double-Blind Trial. Anesth Analg. 2017 Mar;124(3):959-965. doi: 10.1213/ANE.0000000000001811.

  PMID: 28151818 BACKGROUND

• Rickard CM, Marsh N, Webster J, Playford EG, McGrail MR, Larsen E, Keogh S, McMillan D, Whitty JA, Choudhury MA, Dunster KR, Reynolds H, Marshall A, Crilly J, Young J, Thom O, Gowardman J, Corley A, Fraser JF. Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial. BMJ Open. 2015 Sep 23;5(9):e008689. doi: 10.1136/bmjopen-2015-008689.

  PMID: 26399574 BACKGROUND

• Bugden S, Shean K, Scott M, Mihala G, Clark S, Johnstone C, Fraser JF, Rickard CM. Skin Glue Reduces the Failure Rate of Emergency Department-Inserted Peripheral Intravenous Catheters: A Randomized Controlled Trial. Ann Emerg Med. 2016 Aug;68(2):196-201. doi: 10.1016/j.annemergmed.2015.11.026. Epub 2015 Dec 31.

  PMID: 26747220 BACKGROUND

• Reynolds H, Taraporewalla K, Tower M, Mihala G, Tuffaha HW, Fraser JF, Rickard CM. Novel technologies can provide effective dressing and securement for peripheral arterial catheters: A pilot randomised controlled trial in the operating theatre and the intensive care unit. Aust Crit Care. 2015 Aug;28(3):140-8. doi: 10.1016/j.aucc.2014.12.001. Epub 2015 Jan 9.

  PMID: 25583412 BACKGROUND

• Ozkula U, Ozhasenekler A, Kurtoglu Celik G, Tanriverdi F, Pamukcu Gunaydin G, Ergin M, Yildirim C, Gokhan S. Tissue adhesives to secure peripheral intravenous catheters: A randomized controlled trial in patients over 65 years. Turk J Emerg Med. 2018 Aug 23;19(1):12-15. doi: 10.1016/j.tjem.2018.08.003. eCollection 2019 Jan.

  PMID: 30793059 BACKGROUND

• Wilkinson JN, Chikhani M, Mortimer K, Gill SJ. The antimicrobial effect of Histoacryl skin adhesive. Anaesthesia. 2008 Dec;63(12):1382-4. doi: 10.1111/j.1365-2044.2008.05775.x. No abstract available.

  PMID: 19032320 BACKGROUND

• Wilkinson JN, Fitz-Henry J. Securing epidural catheters with Histoacryl glue. Anaesthesia. 2008 Mar;63(3):324. doi: 10.1111/j.1365-2044.2008.05468.x. No abstract available.

  PMID: 18289253 BACKGROUND

• Prachanpanich N, Morakul S, Kiatmongkolkul N. Effectiveness of securing central venous catheters with topical tissue adhesive in patients undergoing cardiac surgery: a randomized controlled pilot study. BMC Anesthesiol. 2021 Mar 8;21(1):70. doi: 10.1186/s12871-021-01282-0.

  PMID: 33685394 BACKGROUND

• King KC, Strony R. Needlestick. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493147/

  PMID: 29630199 BACKGROUND

Study Officials

• Peter Richman

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Research Director, Department of Emergency Medicine, CHRISTUS Health/Texas A&M College of Medicine, Residency in Emergency Medicine

Model Details: Patients were randomized to line securement with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: September 19, 2024
• Study Start: June 15, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)