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Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach

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ClinicalTrials.gov Identifier: NCT03920423
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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 Intervention/treatment Phase
Radial Artery Catheterization Ultrasound or Ultrasonography Ultrasound-guided Short-axis Out-of-plane Dynamic Approach Procedure: improvement of arterial depth Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

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.

No Intervention: deep depth
Radial arterial deth is deep than the cutoff point that relative to results.



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920423


Contacts
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Contact: Yuan Tian 18810261573 ext 18810261573 counsissis@sina.com
Contact: Chunhua Yu 01069152030 chhyu@pumch.cn

Sponsors and Collaborators
Peking Union Medical College Hospital

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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: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No