Ultrasound Therapy; ComplicationsNCT04382430
Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation
A study testing Ultrasound guided venous access and Conventional technique in people with Ultrasound Therapy; Complications and Cardiac Device Implant, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ultrasound Therapy; Complications, Cardiac Device Implant, Venous Access
- What is being tested?
- Ultrasound guided venous access and Conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2020to 6 Jun 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written Informed Consent Form.
- ≥18 years of age up to 90 years old.
- Eligible and referred for cardiac device implantation.
- BMI < 35.
Who cannot join
- Unable to sign consent.
- Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) \& leadless devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.
Read the detailed description
Ultrasound (US) guided axillary vein access for device implantation is an uncommon approach to gain venous access for cardiac device implantation - an extremely common procedure. However, there has been a growing trend of utilizing this approach to obtain venous access for device implantation among operators. Axillary vein access was described back as far as 1997, when it was utilized for contrast guided venipuncture to access the axillary vein for device implantation. Literature has suggested that an axillary venous approach, with either a superficial landmark or radiographic contrast, has better long-term efficacy and lower lead complications than a conventional subclavian approach for patients that had permanent pacemaker implantation. There are a variety of ways to access the axillary vein including contrast venography to help localization, "blind puncture" (utilizing fluoroscopy to identify anatomical landmarks), and US. More recently, operators have begun to utilize US guidance for axillary vein access. Esmaiel has described that US guidance for axillary vein access could potentially improve the success rate of venous access and limit complications. Others, albeit few, have reported US guided access for cardiac device implantation has the ability to reduce complications, is faster to complete, and easier to learn. According to the Agency for Healthcare Research and Quality in the United States, US guided central venous catheter placement is one of the 11 patient safety practices that have the strongest evidence supporting its use in improving patient outcomes. Evidence supports US guidance being standard of care in central venous catheter placement and using US for axillary access as helpful in cardiac device implantation, but providers still utilize predominantly alternative approaches to obtain venous access via the subclavian vein, cephalic cutdown, extrathoracic axillary using fluoroscopy and thoracic axillary using fluoroscopy.
Currently, there is limited data describing outcomes, the efficiency of US guided axillary access for cardiac device implantation, and the learning curve associated with this technique. Data suggests that utilizing the US approach can improve outcomes, be more efficient, and be easier to learn. Investigators recently reported a high success (95%) and low complication rate with US guided axillary access in 187 patients. Despite this limited data, operators still largely use alternative approaches for venous access. In part, this may be due to the learning curve associated with US axillary venous access.
While there is data demonstrating the utility of US guided axillary access, there is little evidence showing the learning curve for operators associated with this technique. The aim of this project is to assess the learning curve of this technique among operators of various levels of experience.
- Being tested
- Ultrasound guided venous access, Conventional technique
- Keywords
- US Guided Venous access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided venous accessProcedure or surgery
Each physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant.
Conventional techniqueProcedure or surgery
Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation
| Study group | Role | What they receive |
|---|---|---|
| US Guided Axillary venous access | Experimental | Physician/ provider will perform 2 unassisted \& 10 solo Ultrasound (US) guided venous access and pocket creation cardiac device implant. First 2 device implant will be done to educate physicians about ultrasound guided venous access. Subsequent subject will be randomized to 2:1 in ultrasound vs. conventional technique. Receives: Procedure: Ultrasound guided venous access |
| Conventional technique | Active comparator | Physician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation. Receives: Procedure: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous access time between US guided and conventional technique
Assess changes in venous access and pocket creation time with progressive experience with US guided axillary venous access (learning curve).
Measured: During procedure
Time spent for pocket creation between US guided venous access technique and conventional technique.
Compare the pocket creation time with US guided axillary venous access versus conventional techniques.
Measured: During procedure
Time spent to obtain venous access & pocket creation between experienced and inexperienced physicians.
Compare venous access and pocket creation time amongst experienced and inexperienced physicians.
Measured: During procedure
To assess 30 day post procedure complications
Assess 30-day complications between techniques.
Measured: 30 Day post procedure
Assess acute procedural success between two techniques.
Compare overall procedural success whether device was successfully placed or not post procedure between US guided axillary venous access \& conventional technique. Success as Assigned- whether implant technique assigned was successful or whether had to switch to an alternative technique.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start28 May 2020
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- The Study Group for this study will include 1 US experienced Electrophysiology (EP) attending, 4 US inexperienced EP attendings, and 1 US inexperienced EP fellow performing US cardiac device implantation (CDI). Each provider will perform 5 conventional CDI, 2 assisted US CDI to learn the procedure (except for experienced US attending), and 10 solo US CDI for a total of 17 procedures per provider (15 for experienced US attending). 100 patients will be needed for this study. This study will take approximately 16 weeks to complete.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Sheldon, University of Kansas Medical Center
- Investigators
- Seth Sheldon, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382430
- Sponsor's protocol ID
- STUDY00145717
- Status last verified
- Sep 2021
- First submitted
- 3 May 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramza BM, Rosenthal L, Hui R, Nsah E, Savader S, Lawrence JH, Tomaselli G, Berger R, Brinker J, Calkins H. Safety and effectiveness of placement of pacemaker and defibrillator leads in the axillary vein guided by contrast venography. Am J Cardiol. 1997 Oct 1;80(7):892-6. doi: 10.1016/s0002-9149(97)00542-0.
PubMed 9382004Kim KH, Park KM, Nam GB, Kim DK, Oh M, Choi H, Hong TJ, Park BM, Seo GW, Song PS, Kim DK, Seol SH, Kim DI, Kim YH, Choi KJ. Comparison of the axillary venous approach and subclavian venous approach for efficacy of permanent pacemaker implantation. 8-Year follow-up results. Circ J. 2014;78(4):865-71. doi: 10.1253/circj.cj-13-0884. Epub 2014 Mar 3.
PubMed 24583974Squara F, Tomi J, Scarlatti D, Theodore G, Moceri P, Ferrari E. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access. Europace. 2017 Dec 1;19(12):2001-2006. doi: 10.1093/europace/euw363.
PubMed 28064251Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.
PubMed 26880272Jones DG, Stiles MK, Stewart JT, Armstrong GP. Ultrasound-guided venous access for permanent pacemaker leads. Pacing Clin Electrophysiol. 2006 Aug;29(8):852-7. doi: 10.1111/j.1540-8159.2006.00451.x.
PubMed 16923001Seto AH, Jolly A, Salcedo J. Ultrasound-guided venous access for pacemakers and defibrillators. J Cardiovasc Electrophysiol. 2013 Mar;24(3):370-4. doi: 10.1111/jce.12005. Epub 2012 Nov 6.
PubMed 23131025Lin J, Adsit G, Barnett A, Tattersall M, Field ME, Wright J. Feasibility of ultrasound-guided vascular access during cardiac implantable device placement. J Interv Card Electrophysiol. 2017 Oct;50(1):105-109. doi: 10.1007/s10840-017-0273-3. Epub 2017 Jul 27.
PubMed 28752227Liccardo M, Nocerino P, Gaia S, Ciardiello C. Efficacy of ultrasound-guided axillary/subclavian venous approaches for pacemaker and defibrillator lead implantation: a randomized study. J Interv Card Electrophysiol. 2018 Mar;51(2):153-160. doi: 10.1007/s10840-018-0313-7. Epub 2018 Jan 15.
PubMed 29335840
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation
- ClinicalTrials.gov ID
- NCT04382430
- Acronym / sponsor ID
- STUDY00145717
- Keywords
- US Guided Venous access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 11 May 2020 (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.
The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.
Detailed description
Ultrasound (US) guided axillary vein access for device implantation is an uncommon approach to gain venous access for cardiac device implantation - an extremely common procedure. However, there has been a growing trend of utilizing this approach to obtain venous access for device implantation among operators. Axillary vein access was described back as far as 1997, when it was utilized for contrast guided venipuncture to access the axillary vein for device implantation. Literature has suggested that an axillary venous approach, with either a superficial landmark or radiographic contrast, has better long-term efficacy and lower lead complications than a conventional subclavian approach for patients that had permanent pacemaker implantation. There are a variety of ways to access the axillary vein including contrast venography to help localization, "blind puncture" (utilizing fluoroscopy to identify anatomical landmarks), and US. More recently, operators have begun to utilize US guidance for axillary vein access. Esmaiel has described that US guidance for axillary vein access could potentially improve the success rate of venous access and limit complications. Others, albeit few, have reported US guided access for cardiac device implantation has the ability to reduce complications, is faster to complete, and easier to learn. According to the Agency for Healthcare Research and Quality in the United States, US guided central venous catheter placement is one of the 11 patient safety practices that have the strongest evidence supporting its use in improving patient outcomes. Evidence supports US guidance being standard of care in central venous catheter placement and using US for axillary access as helpful in cardiac device implantation, but providers still utilize predominantly alternative approaches to obtain venous access via the subclavian vein, cephalic cutdown, extrathoracic axillary using fluoroscopy and thoracic axillary using fluoroscopy.
Currently, there is limited data describing outcomes, the efficiency of US guided axillary access for cardiac device implantation, and the learning curve associated with this technique. Data suggests that utilizing the US approach can improve outcomes, be more efficient, and be easier to learn. Investigators recently reported a high success (95%) and low complication rate with US guided axillary access in 187 patients. Despite this limited data, operators still largely use alternative approaches for venous access. In part, this may be due to the learning curve associated with US axillary venous access.
While there is data demonstrating the utility of US guided axillary access, there is little evidence showing the learning curve for operators associated with this technique. The aim of this project is to assess the learning curve of this technique among operators of various levels of experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Study Group for this study will include 1 US experienced Electrophysiology (EP) attending, 4 US inexperienced EP attendings, and 1 US inexperienced EP fellow performing US cardiac device implantation (CDI). Each provider will perform 5 conventional CDI, 2 assisted US CDI to learn the procedure (except for experienced US attending), and 10 solo US CDI for a total of 17 procedures per provider (15 for experienced US attending). 100 patients will be needed for this study. This study will take approximately 16 weeks to complete.
| Arm | Type | Receives |
|---|---|---|
| US Guided Axillary venous access | Experimental | Procedure: Ultrasound guided venous accessPhysician/ provider will perform 2 unassisted \& 10 solo Ultrasound (US) guided venous access and pocket creation cardiac device implant. First 2 device implant will be done to educate physicians about ultrasound guided venous access. Subsequent subject will be randomized to 2:1 in ultrasound vs. conventional technique. |
| Conventional technique | Active comparator | Procedure: Conventional techniquePhysician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign written Informed Consent Form.
- ≥18 years of age up to 90 years old.
- Eligible and referred for cardiac device implantation.
- BMI < 35.
Key exclusion criteria (2 listed)
- Unable to sign consent.
- Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) \& leadless devices.
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 |
|---|---|---|
| Ultrasound guided venous accessEach physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant. | Procedure or surgery | US Guided Axillary venous access |
| Conventional techniquePhysician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation | Procedure or surgery | Conventional technique |
Primary outcome
Venous access time between US guided and conventional technique
Time frame: During procedure
Assess changes in venous access and pocket creation time with progressive experience with US guided axillary venous access (learning curve).
Time spent for pocket creation between US guided venous access technique and conventional technique.
Time frame: During procedure
Compare the pocket creation time with US guided axillary venous access versus conventional techniques.
Time spent to obtain venous access & pocket creation between experienced and inexperienced physicians.
Time frame: During procedure
Compare venous access and pocket creation time amongst experienced and inexperienced physicians.
To assess 30 day post procedure complications
Time frame: 30 Day post procedure
Assess 30-day complications between techniques.
Assess acute procedural success between two techniques.
Time frame: During procedure
Compare overall procedural success whether device was successfully placed or not post procedure between US guided axillary venous access \& conventional technique. Success as Assigned- whether implant technique assigned was successful or whether had to switch to an alternative technique.
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 4 Oct 2021.
- Background: PubMed 9382004Ramza BM, Rosenthal L, Hui R, Nsah E, Savader S, Lawrence JH, Tomaselli G, Berger R, Brinker J, Calkins H. Safety and effectiveness of placement of pacemaker and defibrillator leads in the axillary vein guided by contrast venography. Am J Cardiol. 1997 Oct 1;80(7):892-6. doi: 10.1016/s0002-9149(97)00542-0.
- Background: PubMed 24583974Kim KH, Park KM, Nam GB, Kim DK, Oh M, Choi H, Hong TJ, Park BM, Seo GW, Song PS, Kim DK, Seol SH, Kim DI, Kim YH, Choi KJ. Comparison of the axillary venous approach and subclavian venous approach for efficacy of permanent pacemaker implantation. 8-Year follow-up results. Circ J. 2014;78(4):865-71. doi: 10.1253/circj.cj-13-0884. Epub 2014 Mar 3.
- Background: PubMed 28064251Squara F, Tomi J, Scarlatti D, Theodore G, Moceri P, Ferrari E. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access. Europace. 2017 Dec 1;19(12):2001-2006. doi: 10.1093/europace/euw363.
- Background: PubMed 26880272Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.
- Background: PubMed 16923001Jones DG, Stiles MK, Stewart JT, Armstrong GP. Ultrasound-guided venous access for permanent pacemaker leads. Pacing Clin Electrophysiol. 2006 Aug;29(8):852-7. doi: 10.1111/j.1540-8159.2006.00451.x.
- Background: PubMed 23131025Seto AH, Jolly A, Salcedo J. Ultrasound-guided venous access for pacemakers and defibrillators. J Cardiovasc Electrophysiol. 2013 Mar;24(3):370-4. doi: 10.1111/jce.12005. Epub 2012 Nov 6.
- Background: PubMed 28752227Lin J, Adsit G, Barnett A, Tattersall M, Field ME, Wright J. Feasibility of ultrasound-guided vascular access during cardiac implantable device placement. J Interv Card Electrophysiol. 2017 Oct;50(1):105-109. doi: 10.1007/s10840-017-0273-3. Epub 2017 Jul 27.
- Background: PubMed 29335840Liccardo M, Nocerino P, Gaia S, Ciardiello C. Efficacy of ultrasound-guided axillary/subclavian venous approaches for pacemaker and defibrillator lead implantation: a randomized study. J Interv Card Electrophysiol. 2018 Mar;51(2):153-160. doi: 10.1007/s10840-018-0313-7. Epub 2018 Jan 15.
- 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.
Seth Sheldon, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided venous access and Conventional technique in people with Ultrasound Therapy; Complications and Cardiac Device Implant, run by University of Kansas Medical Center 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 4 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 4 Oct 2021. 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?
Venous access time between US guided and conventional technique (time frame: During procedure). The study lists 5 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 NCT04382430, which also lists 8 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 4 Oct 2021.