NCT04730479

Brief Summary

In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

January 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

November 8, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

January 25, 2021

Last Update Submit

November 4, 2022

Conditions

Cardiac and Aortic Surgery

Keywords

ultrasonographyradial artery catheterizationprobabilistic modeladult

Outcome Measures

Primary Outcomes (1)

  • Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists

    Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery.

    Day 1

Secondary Outcomes (11)

  • Internal radial artery diameter

    Day 1

  • External radial artery diameter

    Day 1

  • Internal area of the radial artery

    Day 1

  • External area of the radial artery

    Day 1

  • Calcification of arterial wall (yes/no)

    Day 1

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital

You may qualify if:

  • Aged from 18 years old
  • Be operated for a scheduled cardiac or aortic surgery
  • Be able to complete all the visits and follow the study procedures
  • Subjects must be covered by public health insurance

You may not qualify if:

  • Patients protected by law or Absence of signed informed consent
  • Emergency Surgery Patient
  • Patient already with an arterial catheter
  • Patient with Radial Arterial Catheter Contraindication
  • Radial arterial catheter placed by an anesthesiologist nurse student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

Study Officials

  • Jérôme PANIEGO

    University hospital of Montpellier, Montpellier, France, 34295

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 29, 2021

Study Start

April 15, 2021

Primary Completion

April 6, 2022

Study Completion

April 11, 2022

Last Updated

November 8, 2022

Record last verified: 2022-10

Locations

FR(1)