Vascular Access ComplicationUGVPCNCT03656978
Ultrasound-Guided Vascular Puncture and Catheterization
A study testing dynamic and Regular-triangle in people with Vascular Access Complication and Ultrasound Therapy; Complications, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Ultrasound Therapy; Complications, Perioperative/Postoperative Complications
- What is being tested?
- dynamic and Regular-triangle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 8 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old.
- Scheduled for selective surgery.
- Requirement of perioperative vascular puncture and catheterization.
- American standard of anesthesia level I-IV.
Who cannot join
- Contraindication to vascular puncture or catheterization.
- Occlusion or thrombosis of target vessel evaluated by ultrasound.
- Refuse or disagreement from participants.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.
Read the detailed description
Investigators hypothesized that （1） various ultrasound-guided methods had different performances of vascular puncture and catheterization, (2) certain risk factors influenced safety and success rate of vascular puncture and catheterization (3) implementation of protocols could improve the performances of ultrasound-guided vascular puncture and catheterization.
- Conditions
- Vascular Access Complication, Ultrasound Therapy; Complications, Perioperative/Postoperative Complications, Cardiovascular Abnormalities
- Being tested
- dynamic, Regular-triangle
- Keywords
- vascular access, vascular catheterization, ultrasound-guided, ultrasonography, perioperative, anesthesia, cardiovascular abnormalities
- Medical subject headings
- Postoperative Complications, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamicBehavioural
Use the according methods in dynamic arm descriptions.
Regular-triangleBehavioural
Use the according methods in regular-triangle arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic | Active comparator | Keep moving the probe for needle tip visualization during the puncture procedure. Receives: Behavioral: dynamic |
| Regular-triangle | Placebo comparator | Needle access along the hypotenuse of the regular triangle formed by the vascular depth and puncture point. Receives: Behavioral: Regular-triangle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate without extra vascular damage
Percentages of successful catheterization without vascular damage of posterior wall.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Successful rate at first attempt.
Percentage of successful catheterization at first attempt without needle withdraw.
Measured: Through study completion, an average of 1 year.
Time duration of catheterization.
From beginning of needle puncture to finishing or failing catheterization.
Measured: Through study completion, an average of 1 year.
Relative factors of successful catheterization without posterior wall damage.
Relationship between independent variables (gender, age, BMI, BP, depth and so on) and successful catheterization without posterior wall damage.
Measured: Through study completion, an average of 1 year.
The effect of depth to the successful catheterization without posterior wall puncture.
The relationships between different depth of vascular anterior wall and successful catheterization without posterior wall puncture.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Jun 2017
- Primary completion23 Apr 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunhua Yu, Peking Union Medical College Hospital
- Investigators
- Yu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656978
- Sponsor's protocol ID
- zs-1338
- Acronym
- UGVPC
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Performances of vascular manufacture，such as posterior wall puncture，success at first attempt， overall success or failure and so on. Evaluations of vascular sonography， such as depth，diameter and so on.
Publications
Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19.
PubMed 27761661Goh G, Tan C, Weinberg L. Dynamic ultrasound-guided, short axis, out-of-plane radial artery cannulation: the 'follow the tip' technique. Anaesth Intensive Care. 2013 May;41(3):431-2. No abstract available.
PubMed 23659411Powell JT, Mink JT, Nomura JT, Levine BJ, Jasani N, Nichols WL, Reed J, Sierzenski PR. Ultrasound-guidance can reduce adverse events during femoral central venous cannulation. J Emerg Med. 2014 Apr;46(4):519-24. doi: 10.1016/j.jemermed.2013.08.023. Epub 2014 Jan 22.
PubMed 24462032Nakayama Y, Nakajima Y, Sessler DI, Ishii S, Shibasaki M, Ogawa S, Takeshita J, Shime N, Mizobe T. A novel method for ultrasound-guided radial arterial catheterization in pediatric patients. Anesth Analg. 2014 May;118(5):1019-26. doi: 10.1213/ANE.0000000000000164.
PubMed 24781571Ward F, Faratro R, McQuillan RF. Ultrasound-Guided Cannulation of the Hemodialysis Arteriovenous Access. Semin Dial. 2017 Jul;30(4):319-325. doi: 10.1111/sdi.12603. Epub 2017 May 9.
PubMed 28486776Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011 Jul;39(7):1607-12. doi: 10.1097/CCM.0b013e318218a1ae.
PubMed 21494105Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.
PubMed 26539789Gao YB, Yan JH, Ma JM, Liu XN, Dong JY, Sun F, Tang LW, Li J. Effects of long axis in-plane vs short axis out-of-plane techniques during ultrasound-guided vascular access. Am J Emerg Med. 2016 May;34(5):778-83. doi: 10.1016/j.ajem.2015.12.092. Epub 2016 Jan 6.
PubMed 26830218Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140Bai B, Tian Y, Zhang Y, Yu C, Huang Y. Dynamic needle tip positioning versus the angle-distance technique for ultrasound-guided radial artery cannulation in adults: a randomized controlled trial. BMC Anesthesiol. 2020 Sep 14;20(1):231. doi: 10.1186/s12871-020-01152-1.
PubMed 32928119
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Vascular Puncture and Catheterization
- ClinicalTrials.gov ID
- NCT03656978
- Acronym / sponsor ID
- UGVPC / zs-1338
- Conditions
- Vascular Access Complication, Ultrasound Therapy; Complications, Perioperative/Postoperative Complications, Cardiovascular Abnormalities
- Keywords
- vascular access, vascular catheterization, ultrasound-guided, ultrasonography, perioperative, anesthesia, cardiovascular abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 4 Sep 2018 (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.
To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.
Detailed description
Investigators hypothesized that （1） various ultrasound-guided methods had different performances of vascular puncture and catheterization, (2) certain risk factors influenced safety and success rate of vascular puncture and catheterization (3) implementation of protocols could improve the performances of ultrasound-guided vascular puncture and catheterization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic | Active comparator | Behavioral: dynamicKeep moving the probe for needle tip visualization during the puncture procedure. |
| Regular-triangle | Placebo comparator | Behavioral: Regular-triangleNeedle access along the hypotenuse of the regular triangle formed by the vascular depth and puncture point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years old.
- Scheduled for selective surgery.
- Requirement of perioperative vascular puncture and catheterization.
- American standard of anesthesia level I-IV.
Key exclusion criteria (3 listed)
- Contraindication to vascular puncture or catheterization.
- Occlusion or thrombosis of target vessel evaluated by ultrasound.
- Refuse or disagreement from participants.
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 |
|---|---|---|
| dynamicUse the according methods in dynamic arm descriptions. | Behavioural | Dynamic |
| Regular-triangleUse the according methods in regular-triangle arm descriptions. | Behavioural | Regular-triangle |
Primary outcome
Successful rate without extra vascular damage
Time frame: Through study completion, an average of 1 year.
Percentages of successful catheterization without vascular damage of posterior wall.
4 secondary outcomes
Successful rate at first attempt.
Time frame: Through study completion, an average of 1 year.
Time duration of catheterization.
Time frame: Through study completion, an average of 1 year.
Relative factors of successful catheterization without posterior wall damage.
Time frame: Through study completion, an average of 1 year.
The effect of depth to the successful catheterization without posterior wall puncture.
Time frame: Through study completion, an average of 1 year.
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 18 Sep 2020.
- Background: PubMed 27761661Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19.
- Background: PubMed 23659411Goh G, Tan C, Weinberg L. Dynamic ultrasound-guided, short axis, out-of-plane radial artery cannulation: the 'follow the tip' technique. Anaesth Intensive Care. 2013 May;41(3):431-2. No abstract available.
- Background: PubMed 24462032Powell JT, Mink JT, Nomura JT, Levine BJ, Jasani N, Nichols WL, Reed J, Sierzenski PR. Ultrasound-guidance can reduce adverse events during femoral central venous cannulation. J Emerg Med. 2014 Apr;46(4):519-24. doi: 10.1016/j.jemermed.2013.08.023. Epub 2014 Jan 22.
- Background: PubMed 24781571Nakayama Y, Nakajima Y, Sessler DI, Ishii S, Shibasaki M, Ogawa S, Takeshita J, Shime N, Mizobe T. A novel method for ultrasound-guided radial arterial catheterization in pediatric patients. Anesth Analg. 2014 May;118(5):1019-26. doi: 10.1213/ANE.0000000000000164.
- Background: PubMed 28486776Ward F, Faratro R, McQuillan RF. Ultrasound-Guided Cannulation of the Hemodialysis Arteriovenous Access. Semin Dial. 2017 Jul;30(4):319-325. doi: 10.1111/sdi.12603. Epub 2017 May 9.
- Background: PubMed 21494105Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011 Jul;39(7):1607-12. doi: 10.1097/CCM.0b013e318218a1ae.
- Background: PubMed 26539789Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.
- Background: PubMed 26830218Gao YB, Yan JH, Ma JM, Liu XN, Dong JY, Sun F, Tang LW, Li J. Effects of long axis in-plane vs short axis out-of-plane techniques during ultrasound-guided vascular access. Am J Emerg Med. 2016 May;34(5):778-83. doi: 10.1016/j.ajem.2015.12.092. Epub 2016 Jan 6.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
- Derived from this study: PubMed 32928119Bai B, Tian Y, Zhang Y, Yu C, Huang Y. Dynamic needle tip positioning versus the angle-distance technique for ultrasound-guided radial artery cannulation in adults: a randomized controlled trial. BMC Anesthesiol. 2020 Sep 14;20(1):231. doi: 10.1186/s12871-020-01152-1.
- Individual participant dataSharing planned: Undecided. Performances of vascular manufacture，such as posterior wall puncture，success at first attempt， overall success or failure and so on. Evaluations of vascular sonography， such as depth，diameter and so on.
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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.
Yu study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic and Regular-triangle in people with Vascular Access Complication and Ultrasound Therapy; Complications, run by Peking Union Medical College Hospital at 1 site in China.
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 3 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 18 Sep 2020. 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 China. 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. Some participants in this study may receive a placebo. 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?
Successful rate without extra vascular damage (time frame: Through study completion, an average of 1 year.). 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 NCT03656978, which also lists 10 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 18 Sep 2020.