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Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03920423
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Procedure: improvement of arterial depth
 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 :
Apr 22, 2019
Actual Primary Completion Date :
Jan 17, 2020
Actual Study Completion Date :
Jan 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. success without posterior wall puncture [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 [Through study completion,an average of 5 minutes]

    success puncture and catheterization in first attempt

Secondary Outcome Measures

  1. success overall [Through study completion,an average of 5 minutes]

    success catheterization with the maximum of 10 minutes

  2. time needed to catheterization [Through study completion,an average of 5 minutes]

    time required for successful puncturing and catheterization with the maximum of 10 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03920423
Other Study ID Numbers:
  • 1338
First Posted:
Apr 18, 2019
Last Update Posted:
Aug 31, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 31, 2020