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Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?

Primary Purpose

Catheterization, Central Venous

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Catheterization, Central Venous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Christiana Care Heath System

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CVC Internal Jugular or Subclavian Vein

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time needed to complete the US exam and CXR

Full Information

First Posted
October 12, 2006
Last Updated
October 17, 2014
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00388375
Brief Title
Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?
Official Title
Can Ultrasound be Used as an Alternative to Chest Radiography After Central Venous Catheter Insertion to Confirm Proper Catheter Position and to Exclude Pneumothorax?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Not feasible, did not have the study population.
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

5. Study Description

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.
Detailed Description
Central venous catheterization (CVC) of the subclavian or internal jugular veins is a common procedure performed in the emergency department (ED). This procedure is followed by complications in 0.3 to 12% of cases. Pneumothorax (PTX) and catheter-tip misplacement can occur. The diagnosis of these complications requires a chest radiograph (CXR). In certain cases, CXR may be time-consuming, requiring more than 30 minutes. This could be harmful in the case of critically ill patients. Moreover, several investigators have questioned the need of routine post-procedural CXR in the absence of clinical complications. Recent data has shown that ultrasound can accurately detect PTX in critically ill patients. Furthermore, bedside ultrasound is an easy technique to investigate the subclavian and internal jugular veins, and can improve the success rate of catheter insertion. Ultrasound also allows visualization of central venous catheters in vivo. Ultrasound has been reported as a tool to detect catheterization complications and misplacement when performed by ICU physicians, but has never been studied in the ED. This method could be valuable in hemodynamically unstable patients, who quickly need a CVC for the measurement of central venous pressure, immediate fluid resuscitation, and infusion of vasoactive medications. Similarly, bedside ultrasound examination could quickly confirm PTX and allow immediate chest tube insertion in case of respiratory distress after catheter insertion. We hypothesize that bedside ultrasound examination performed by ED physicians could accurately detect placement of the CVC and the presence or absence of a PTX after catheterization of the jugular and subclavian veins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheterization, Central Venous

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVC Internal Jugular or Subclavian Vein
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
The presence or absence of a misplaced CVC as detected by US and CXR.
Time Frame
10 Minutes
Title
The presence or absence of PTX as detected by US and CXR
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Time needed to complete the US exam and CXR
Time Frame
varies

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female 18 years or older Signed consent In need of subclavian or internal jugular central line placement Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Nomura, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Heath System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

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Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?

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