NCT03130660

Brief Summary

We plan to compare single person short axis view with two person long axis view

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

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

Study Start

First participant enrolled

April 20, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

April 22, 2017

Last Update Submit

August 7, 2018

Conditions

UltrasonographyCentral Line Complication

Keywords

central lineCentral Line Complication

Outcome Measures

Primary Outcomes (1)

  • time to insertion

    time from skin puncture to insertion of guidewire

    15 minutes

Secondary Outcomes (3)

  • Total Procedure time

    15 minutes

  • Number of needle sticks

    15 minutes

  • Complications

    48 hours

Study Arms (2)

Short Axis Ultrasonography

EXPERIMENTAL

one person does both ultrasound and line insertion

Device: Ultrasonography

Long Axis Ultrasonography

EXPERIMENTAL

one person does ultrasound and another inserts the central line

Device: Ultrasonography

Interventions

UltrasonographyDEVICE

Ultrasound guidance for central line

Long Axis UltrasonographyShort Axis Ultrasonography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient getting admitted to ICU and requiring central venous cannulations.

You may not qualify if:

  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMS and SUM Hospital

Bhubaneswar, Odisha, 751007, India

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Arun Rath, MD

    IMS and Sum hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: patient to be randomized to two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2017

First Posted

April 26, 2017

Study Start

April 20, 2017

Primary Completion

April 19, 2018

Study Completion

April 19, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

IN(1)