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Ultrasound-Guided Vascular Puncture and Catheterization (UGVPC)

Primary Purpose

Vascular Access Complication, Ultrasound Therapy; Complications, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dynamic
Regular-triangle
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vascular Access Complication focused on measuring vascular access, vascular catheterization, ultrasound-guided, ultrasonography, perioperative, anesthesia, cardiovascular abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dynamic

Regular-triangle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Successful rate without extra vascular damage
Percentages of successful catheterization without vascular damage of posterior wall.

Secondary Outcome Measures

Successful rate at first attempt.
Percentage of successful catheterization at first attempt without needle withdraw.
Time duration of catheterization.
From beginning of needle puncture to finishing or failing catheterization.
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.
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.

Full Information

First Posted
August 21, 2018
Last Updated
September 16, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03656978
Brief Title
Ultrasound-Guided Vascular Puncture and Catheterization
Acronym
UGVPC
Official Title
Ultrasound-Guided Vascular Puncture and Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 23, 2018 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication, Ultrasound Therapy; Complications, Perioperative/Postoperative Complications, Cardiovascular Abnormalities
Keywords
vascular access, vascular catheterization, ultrasound-guided, ultrasonography, perioperative, anesthesia, cardiovascular abnormalities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic
Arm Type
Active Comparator
Arm Description
Keep moving the probe for needle tip visualization during the puncture procedure.
Arm Title
Regular-triangle
Arm Type
Placebo Comparator
Arm Description
Needle access along the hypotenuse of the regular triangle formed by the vascular depth and puncture point.
Intervention Type
Behavioral
Intervention Name(s)
dynamic
Intervention Description
Use the according methods in dynamic arm descriptions.
Intervention Type
Behavioral
Intervention Name(s)
Regular-triangle
Intervention Description
Use the according methods in regular-triangle arm descriptions.
Primary Outcome Measure Information:
Title
Successful rate without extra vascular damage
Description
Percentages of successful catheterization without vascular damage of posterior wall.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Successful rate at first attempt.
Description
Percentage of successful catheterization at first attempt without needle withdraw.
Time Frame
Through study completion, an average of 1 year.
Title
Time duration of catheterization.
Description
From beginning of needle puncture to finishing or failing catheterization.
Time Frame
Through study completion, an average of 1 year.
Title
Relative factors of successful catheterization without posterior wall damage.
Description
Relationship between independent variables (gender, age, BMI, BP, depth and so on) and successful catheterization without posterior wall damage.
Time Frame
Through study completion, an average of 1 year.
Title
The effect of depth to the successful catheterization without posterior wall puncture.
Description
The relationships between different depth of vascular anterior wall and successful catheterization without posterior wall puncture.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years old. Scheduled for selective surgery. Requirement of perioperative vascular puncture and catheterization. American standard of anesthesia level I-IV. Exclusion Criteria: Contraindication to vascular puncture or catheterization. Occlusion or thrombosis of target vessel evaluated by ultrasound. Refuse or disagreement from participants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
27761661
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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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.
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PubMed Identifier
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Citation
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.
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Citation
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Results Reference
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Ultrasound-Guided Vascular Puncture and Catheterization

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