NCT00388375

Brief Summary

The purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration 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

Study Start

First participant enrolled

October 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 20, 2014

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

October 12, 2006

Last Update Submit

October 17, 2014

Conditions

Catheterization, Central Venous

Outcome Measures

Primary Outcomes (2)

  • The presence or absence of a misplaced CVC as detected by US and CXR.

    10 Minutes

  • The presence or absence of PTX as detected by US and CXR

    10 minutes

Secondary Outcomes (1)

  • Time needed to complete the US exam and CXR

    varies

Study Arms (1)

CVC Internal Jugular or Subclavian Vein

NO INTERVENTION
Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

limited ultrasound examination to evaluate the following areas: Examination of the subclavian and internal jugular veins to assess proper catheter placement PTX detection, using lung sliding and comet-tail artifact Visualization of the heart (right atrium and ventricle) and the inferior vena cava through the subcostal window

CVC Internal Jugular or Subclavian Vein

Eligibility Criteria

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

You may qualify if:

  • Male or female 18 years or older
  • Signed consent
  • In need of subclavian or internal jugular central line placement

You may not qualify if:

  • Any subject who refuses or whose family refuses to sign consent
  • Any subject in whose immediate transfer from the care of the ED to another location is mandated by clinical presentation
  • Any subject under the age of 18
  • Any subject being evaluated for chest trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Heath System

Newark, Delaware, 19718, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Jason Nomura, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 16, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 20, 2014

Record last verified: 2012-11

Locations

US(1)