Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach

August 27, 2020 updated by: Peking Union Medical College Hospital

Impact Factors to Success Without Posterior Wall Puncture Using Ultrasound-guided Short-axis Out-of-plane Dynamic Approach

The study is designed to evaluate and validate impact factors to success and complication using ultrasound guided short-axis out-of-plane dynamic approach, and validate the impaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study including two phase: observational phase and validation phase. In observational phase, factors relative to success catheterization without posterior puncture and success in first attempt are evaluated. In validation phase, patients are randomized into different depth group with or without injection of saline. Success without posterior wall puncture, success in first attempt and overall, catheterization time are compared between groups.

Study Type

Interventional

Enrollment (Actual)

60

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, 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:

  • requirement of radial arterial catheterization during perioperative period
  • within cardiac-vascular disease
  • written consent

Exclusion Criteria:

  • contraindication to radial arterial catheterization
  • abnormal artery evaluated by ultrasonography

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: shallow depth
Radial arterial deth is shallow than the cutoff point that relative to results.
Experimental: improved depth
Radial arterial deth is shallow than the cutoff point that relative to results, and increased by injection of saline to more than deep cutoff point.
Procedure: improvement of arterial depth
deepen radial arterial depth by injection of saline to more than deep cutoff point relative to result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success without posterior wall puncture
Time Frame: Through study completion,an average of 5 minutes
success to puncture and catheterize of radial artery, without posterior wall puncture.
Through study completion,an average of 5 minutes
success in first attempt
Time Frame: Through study completion,an average of 5 minutes
success puncture and catheterization in first attempt
Through study completion,an average of 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success overall
Time Frame: Through study completion,an average of 5 minutes
success catheterization with the maximum of 10 minutes
Through study completion,an average of 5 minutes
time needed to catheterization
Time Frame: Through study completion,an average of 5 minutes
time required for successful puncturing and catheterization with the maximum of 10 minutes
Through study completion,an average of 5 minutes

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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)

April 22, 2019

Primary Completion (Actual)

January 17, 2020

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 1338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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