NCT03523533

Brief Summary

This is an observational study intended to characterize the time-to-placement of peripherally-inserted internal jugular (PIJ) catheters in appropriate patients. As secondary outcomes and to ensure patient safety, the investigators will record and evaluate adverse outcomes, but the study is not powered to detect rare events.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 9, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

May 1, 2018

Results QC Date

May 24, 2023

Last Update Submit

March 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Catheter Placement Time

    Elapsed time from first contact of skin prep solution to completely secured/covered catheter

    No more than 20 minutes

Secondary Outcomes (4)

  • Location of Insertion

    No more than 20 minutes

  • Depth of Insertion

    No more than 20 minutes

  • Number of Attempts

    No more than 20 minutes

  • Number of Participants Experiencing Catheter-related Complications

    1 week

Study Arms (1)

Peripherally-inserted internal jugular catheter

EXPERIMENTAL

All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.

Procedure: Angiocatheter

Interventions

AngiocatheterPROCEDURE

Placement of angiocatheter in internal jugular vein

Peripherally-inserted internal jugular catheter

Eligibility Criteria

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

You may qualify if:

  • require a second intravenous access line (IV) as determined by the anesthesiologist, \*or\*
  • require a primary IV \*and\* are determined by the anesthesiologist to have difficult IV access, defined as two or more failed attempts at peripheral IV placement, in the absence of an indication for a central venous catheter.

You may not qualify if:

  • Infection over the intended peripheral angiocatheter insertion site
  • Cervical spine injury or instability
  • Known abnormal neck anatomy
  • Pregnancy
  • Prisoners
  • Clinical indication for central venous catheter
  • Any pre-existing suspicion for bacteremia
  • Adults unable to consent, as determined by ability to provide consent for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

Results Point of Contact

Title
Dr. Tim Petersen
Organization
University of New Mexico Health Sciences Center (HSC)

Study Officials

  • Tony Yen, MD

    University of New Mexico Health Sciences Center (HSC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is an observational study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 14, 2018

Study Start

August 3, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

March 12, 2024

Results First Posted

February 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations