NCT03455348

Brief Summary

Dysfunctions radial arterial catheter are frequent. This was a prospective, randomized observational study monocentric in ICU in France. Patients are randomized in 2 groups : One to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B). The primary outcome was the incidence of catheter dysfunction (defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve). Investigators compared also the incidence of infection, satisfaction of doctors and nurses, the numbers of days with catheter and the cause of withdrawal.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 6, 2018

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

October 4, 2017

Last Update Submit

February 27, 2018

Conditions

Dysfunctions Arterial Catheter

Outcome Measures

Primary Outcomes (1)

  • the incidence of dysfunction motivating catheter removal as a function of the distance from the carpal radio joint.

    The dysfunction is defined by the impossibility of taking blood from the catheter and / or the impossibility having a reliable blood pressure curve

    through study completion- 2 months

Study Arms (2)

cathete to less than 4 four centimeters to the wrist joint

NO INTERVENTION

catheter to more than four centimeters to the wrist joint

ACTIVE COMPARATOR
Other: catheter insertion

Interventions

catheter insertionOTHER

catheter insertion one to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B)

catheter to more than four centimeters to the wrist joint

Eligibility Criteria

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

You may qualify if:

  • all patients admitted in ICU, older than 18 years and who required an arterial catheter are include

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

March 6, 2018

Study Start

January 22, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 6, 2018

Record last verified: 2017-12