NCT01914705

Brief Summary

The objective of the study is to investigate whether or not there will be a significant difference between landmark vs. ultrasound guided approach during Subclavian Central Venous Catheter (SCVC) placement in terms of the success rate, the time it takes to perform the procedure and the complication rate. By using ultrasound to identify anatomical structures that are not seen during the landmark approach, the investigators hypothesize that both the procedural time and the complication rate of ultrasound guided approach should be lower than the landmark approach. The investigators hypothesize that the success rate will be higher in the ultrasound group.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.7 years

First QC Date

July 31, 2013

Last Update Submit

August 7, 2015

Conditions

Hypotensive

Keywords

LandmarkUltrasoundcentral venous catheter

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    Measure whether or not the physician was able to successfully place the subclavian central venous catheter (SCVC).

    30 minutes

Secondary Outcomes (1)

  • Procedure Time

    30 minutes

Other Outcomes (1)

  • Complication Rate

    30 minutes

Study Arms (2)

Landmark Procedure

ACTIVE COMPARATOR

Using Landmarks to guide SCVC placement

Procedure: Landmark Procedure

Ultrasound Guided Procedure

ACTIVE COMPARATOR

Using ultrasound to guide SCVC placement

Procedure: Ultrasound Guided Procedure

Interventions

Landmark ProcedurePROCEDURE

Using Landmarks to guide SCVC placement

Landmark Procedure
Ultrasound Guided ProcedurePROCEDURE

Using ultrasound to guide SCVC placement

Ultrasound Guided Procedure

Eligibility Criteria

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

You may qualify if:

  • Emergency Department Adult Patients
  • Need placement of subclavian central venous catheter

You may not qualify if:

  • Patients with known coagulopathy
  • Patients with history of subclavian thrombosis
  • Patients with history of vascular injury
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Study Officials

  • John Marshall, MD

    Maimonides Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 10, 2015

Record last verified: 2015-07

Locations

US(1)