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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach

  • Clinicaltrials.gov identifier

    NCT03920423

  • Recruitment Status

    Completed

  • First Posted

    April 18, 2019

  • Last update posted

    August 31, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Radial Artery Catheterization
    Ultrasound or Ultrasonography
    Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
  • Intervention/Treatment: Procedure: improvement of arterial depth
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Supportive Care
  • Official Title: Impact Factors to Success Without Posterior Wall Puncture Using Ultrasound-guided Short-axis Out-of-plane Dynamic Approach
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020

Arms and interventions

Arm Intervention/treatment
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.

Outcome Measures

  • Primary Outcome Measures: 1. 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.
  • 2. success in first attempt [ Time Frame: Through study completion,an average of 5 minutes ]
    success puncture and catheterization in first attempt
  • Secondary Outcome Measures: 1. success overall [ Time Frame: Through study completion,an average of 5 minutes ]
    success catheterization with the maximum of 10 minutes
  • 2. 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Locations

China
Peking Union Medical College Hospital
Beijing

Sponsors and Collaborators

Peking Union Medical College Hospital

More Information

  • Responsible Party: Peking Union Medical College Hospital
  • ClinicalTrials.gov Identifier: NCT03920423 History of Changes
  • Other Study ID Numbers: 1338
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: August 31, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No