Arterial CathetersNCT06589284
Skin Glue Versus Suture for Securing Radial Arterial Lines
A study testing Silk 0-0 suture covered by chlorhexidine gluconate dressing and 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing in people with Arterial Catheters and Catheter Related Complication, run by CHRISTUS Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arterial Catheters, Catheter Related Complication
- What is being tested?
- Silk 0-0 suture covered by chlorhexidine gluconate dressing and 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Require invasive blood pressure monitoring via radial arterial catheter
Who cannot join
- Under 18 years of age
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
CHRISTUS Spohn Hospital Corpus Christi - Shoreline
Corpus Christi, Texas, 78404
About this study
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.
Read the detailed description
This was a prospective, randomized, controlled, trial for which the investigators enrolled a convenience sample of consenting, non-pregnant, adult patients who received an r-a-line in the ICU or ED at a community-based, teaching hospital. After randomization, lines were secured with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing. Patients were followed for duration of line placement and for the occurrence of premature line failure. Categorical data were analyzed by chi-square; continuous data by t-tests.
- Conditions
- Arterial Catheters, Catheter Related Complication
- Being tested
- Silk 0-0 suture covered by chlorhexidine gluconate dressing, 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing
- Keywords
- 2-octyl cyanoacrylate, Central lines, Peripheral lines, Glue, Suture, Chlorhexidine gluconate dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk 0-0 suture covered by chlorhexidine gluconate dressingProcedure or surgery
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 dressingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
Evaluation of patient demographics for line failure
Secondary outcomes included an evaluation of patient and line placement demographics for line failure between both suture and skin glue groups.
Measured: 12 months
Evaluation of line placement for line failure
Secondary outcomes included an evaluation of patient and line placement demographics for line failure between both suture and skin glue groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jun 2023
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Arterial CathetersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to line securement with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Richman, MD, CHRISTUS Health
- Investigators
- Peter Richman, Principal investigator, CHRISTUS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589284
- Sponsor's protocol ID
- 2022078
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12133178Simonova 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.
PubMed 22577911Wilkinson 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.
PubMed 17697235Auyong 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.
PubMed 28151818Rickard 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.
PubMed 26399574Bugden 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.
PubMed 26747220Reynolds 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.
PubMed 25583412Ozkula 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.
PubMed 30793059Wilkinson 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.
PubMed 19032320Wilkinson 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.
PubMed 18289253Prachanpanich 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.
PubMed 33685394King KC, Strony R. Needlestick. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493147/
PubMed 29630199
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Glue Versus Suture for Securing Radial Arterial Lines
- ClinicalTrials.gov ID
- NCT06589284
- Acronym / sponsor ID
- 2022078
- Conditions
- Arterial Catheters, Catheter Related Complication
- Keywords
- 2-octyl cyanoacrylate, Central lines, Peripheral lines, Glue, Suture, Chlorhexidine gluconate dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a prospective, randomized, controlled, trial for which the investigators enrolled a convenience sample of consenting, non-pregnant, adult patients who received an r-a-line in the ICU or ED at a community-based, teaching hospital. After randomization, lines were secured with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing. Patients were followed for duration of line placement and for the occurrence of premature line failure. Categorical data were analyzed by chi-square; continuous data by t-tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized to line securement with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing.
| Arm | Type | Receives |
|---|---|---|
| Silk 0-0 suture covered by chlorhexidine gluconate dressing | Other | Procedure: Silk 0-0 suture covered by chlorhexidine gluconate dressingThe provider will be asked to use standard straight suturing technique followed by a tegaderm dressing for securing the radial arterial catheter. |
| 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing | Other | Procedure: 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressingThe provider will be asked to use skin glue in a standardized fashion followed by a tegaderm dressing for securing the radial arterial catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be at least 18 years of age
- Require invasive blood pressure monitoring via radial arterial catheter
Key exclusion criteria (2 listed)
- Under 18 years of age
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk 0-0 suture covered by chlorhexidine gluconate dressingThe 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. | Procedure or surgery | Silk 0-0 suture covered by chlorhexidine gluconate dressing |
| 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressingThe 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. | Procedure or surgery | 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing |
Primary outcome
Length of time which the catheter remained in place
Time frame: 12 months
Primary outcomes measured were length of time of which the catheter remained in place and causes of premature failure, if it occurred.
Cause of premature failure (if occurred)
Time frame: 12 months
Primary outcomes measured were length of time of which the catheter remained in place and causes of premature failure, if it occurred.
2 secondary outcomes
Evaluation of patient demographics for line failure
Time frame: 12 months
Evaluation of line placement for line failure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 12133178Scheer 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.
- Background: PubMed 22577911Simonova 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.
- Background: PubMed 17697235Wilkinson 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.
- Background: PubMed 28151818Auyong 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.
- Background: PubMed 26399574Rickard 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.
- Background: PubMed 26747220Bugden 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.
- Background: PubMed 25583412Reynolds 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.
- Background: PubMed 30793059Ozkula 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.
- Background: PubMed 19032320Wilkinson 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.
- Background: PubMed 18289253Wilkinson 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.
- Background: PubMed 33685394Prachanpanich 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.
- Background: PubMed 29630199King KC, Strony R. Needlestick. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493147/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Richman principal investigator
CHRISTUS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silk 0-0 suture covered by chlorhexidine gluconate dressing and 2-octyl cyanoacrylate covered by chlorhexidine gluconate dressing in people with Arterial Catheters and Catheter Related Complication, run by CHRISTUS Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time which the catheter remained in place (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589284, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.