Ultrasound-Guided Vascular Puncture and Catheterization (UGVPC)

September 16, 2020 updated by: Chunhua Yu, Peking Union Medical College Hospital
To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dynamic
Keep moving the probe for needle tip visualization during the puncture procedure.
Behavioral: dynamic
Use the according methods in dynamic arm descriptions.
Placebo Comparator: Regular-triangle
Needle access along the hypotenuse of the regular triangle formed by the vascular depth and puncture point.
Behavioral: Regular-triangle
Use the according methods in regular-triangle arm descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful rate at first attempt.
Time Frame: Through study completion, an average of 1 year.
Percentage of successful catheterization at first attempt without needle withdraw.
Through study completion, an average of 1 year.
Time duration of catheterization.
Time Frame: Through study completion, an average of 1 year.
From beginning of needle puncture to finishing or failing catheterization.
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.
Relationship between independent variables (gender, age, BMI, BP, depth and so on) and 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.
Time Frame: Through study completion, an average of 1 year.
The relationships between different depth of vascular anterior wall and successful catheterization without posterior wall puncture.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Yu, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

April 23, 2018

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zs-1338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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