NCT03920423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

April 15, 2019

Last Update Submit

August 27, 2020

Conditions

Radial Artery CatheterizationUltrasound or UltrasonographyUltrasound-guided Short-axis Out-of-plane Dynamic Approach

Outcome Measures

Primary Outcomes (2)

  • success without posterior wall puncture

    success to puncture and catheterize of radial artery, without posterior wall puncture.

    Through study completion,an average of 5 minutes

  • success in first attempt

    success puncture and catheterization in first attempt

    Through study completion,an average of 5 minutes

Secondary Outcomes (2)

  • success overall

    Through study completion,an average of 5 minutes

  • time needed to catheterization

    Through study completion,an average of 5 minutes

Study Arms (2)

shallow depth

NO INTERVENTION

Radial arterial deth is shallow than the cutoff point that relative to results.

improved depth

EXPERIMENTAL

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

Interventions

improvement of arterial depthPROCEDURE

deepen radial arterial depth by injection of saline to more than deep cutoff point relative to result.

improved depth

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 18, 2019

Study Start

April 22, 2019

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)