NCT02973841

Brief Summary

A novel device attached to ultrasound probe designed to increase success rate and safety of internal jugular vein cannulation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Status
unknown

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

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.4 years

First QC Date

November 22, 2016

Last Update Submit

November 23, 2016

Conditions

Internal Jugular Vein Cannulation

Outcome Measures

Primary Outcomes (1)

  • complications rate

    hematoma-arterial puncture-pneumothorax

    24 hours

Study Arms (1)

Sono-ease group

EXPERIMENTAL

insertion IJV catheter using sono-ease device

Device: Sono-ease device

Interventions

Sono-ease deviceDEVICE

insertion of US guided IJV using sono-ease device

Sono-ease group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all patients indicated for IJV catheterization

You may not qualify if:

  • neck deformities-coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

February 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share