NCT03656978

Brief Summary

To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

August 21, 2018

Last Update Submit

September 16, 2020

Conditions

Vascular Access ComplicationUltrasound Therapy; ComplicationsPerioperative/Postoperative ComplicationsCardiovascular Abnormalities

Keywords

vascular accessvascular catheterizationultrasound-guidedultrasonographyperioperativeanesthesiacardiovascular abnormalities

Outcome Measures

Primary Outcomes (1)

  • Successful rate without extra vascular damage

    Percentages of successful catheterization without vascular damage of posterior wall.

    Through study completion, an average of 1 year.

Secondary Outcomes (4)

  • Successful rate at first attempt.

    Through study completion, an average of 1 year.

  • Time duration of catheterization.

    Through study completion, an average of 1 year.

  • Relative factors of successful catheterization without posterior wall damage.

    Through study completion, an average of 1 year.

  • The effect of depth to the successful catheterization without posterior wall puncture.

    Through study completion, an average of 1 year.

Study Arms (2)

Dynamic

ACTIVE COMPARATOR

Keep moving the probe for needle tip visualization during the puncture procedure.

Behavioral: dynamic

Regular-triangle

PLACEBO COMPARATOR

Needle access along the hypotenuse of the regular triangle formed by the vascular depth and puncture point.

Behavioral: Regular-triangle

Interventions

dynamicBEHAVIORAL

Use the according methods in dynamic arm descriptions.

Dynamic
Regular-triangleBEHAVIORAL

Use the according methods in regular-triangle arm descriptions.

Regular-triangle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years old.
  • Scheduled for selective surgery.
  • Requirement of perioperative vascular puncture and catheterization.
  • American standard of anesthesia level I-IV.

You may not qualify if:

  • Contraindication to vascular puncture or catheterization.
  • Occlusion or thrombosis of target vessel evaluated by ultrasound.
  • Refuse or disagreement from participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (10)

  • 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.

    PMID: 27761661BACKGROUND

  • Goh 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.

    PMID: 23659411BACKGROUND

  • Powell 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.

    PMID: 24462032BACKGROUND

  • Nakayama 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.

    PMID: 24781571BACKGROUND

  • Ward 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.

    PMID: 28486776BACKGROUND

  • Fragou 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.

    PMID: 21494105BACKGROUND

  • Reusz 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.

    PMID: 26539789BACKGROUND

  • Gao 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.

    PMID: 26830218BACKGROUND

  • Flumignan 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.

    PMID: 34637140DERIVED

  • Bai 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.

    PMID: 32928119DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsCardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yu

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

September 4, 2018

Study Start

June 1, 2017

Primary Completion

April 23, 2018

Study Completion

March 8, 2019

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

CN(1)