NCT02941094

Brief Summary

Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

July 19, 2016

Last Update Submit

November 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • success rate

    24 hours starting from central line insertion

Study Arms (3)

angle 30 group

ACTIVE COMPARATOR

During central line insertion, After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 30-40 degree.

Device: needle PLT-805ATDevice: Ultrasound

angle 50 group

ACTIVE COMPARATOR

During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 50-60 degree

Device: needle PLT-805ATDevice: Ultrasound

angle 70 group

ACTIVE COMPARATOR

During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 60-80 degree

Device: needle PLT-805ATDevice: Ultrasound

Interventions

comparing success rate and complications using different needle to US probe angles.

Also known as: PLT-805AT, 8 MHz, Toshiba Tokyo, Japan
angle 30 groupangle 50 groupangle 70 group

Xario, Toshiba Tokyo Japan

angle 30 groupangle 50 groupangle 70 group

Eligibility Criteria

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

You may qualify if:

  • all patients requiring central line insertion

You may not qualify if:

  • refusal
  • coagulopathy
  • neck surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 19, 2016

First Posted

October 21, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations