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

This study has been terminated.
(Not feasible, did not have the study population.)
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00388375
First received: October 12, 2006
Last updated: October 17, 2014
Last verified: November 2012

October 12, 2006
October 17, 2014
October 2006
December 2008   (final data collection date for primary outcome measure)
  • The presence or absence of a misplaced CVC as detected by US and CXR. [ Time Frame: 10 Minutes ] [ Designated as safety issue: Yes ]
  • The presence or absence of PTX as detected by US and CXR [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00388375 on ClinicalTrials.gov Archive Site
Time needed to complete the US exam and CXR [ Time Frame: varies ] [ Designated as safety issue: No ]
Time needed to complete the US exam and CXR
Not Provided
Not Provided
 
Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?
Can Ultrasound be Used as an Alternative to Chest Radiography After Central Venous Catheter Insertion to Confirm Proper Catheter Position and to Exclude Pneumothorax?

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Catheterization, Central Venous
Procedure: Ultrasound
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
No Intervention: CVC Internal Jugular or Subclavian Vein
Intervention: Procedure: Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388375
25185
Not Provided
Christiana Care Health Services
Christiana Care Health Services
Not Provided
Principal Investigator: Jason Nomura, MD Christiana Care Health Services
Christiana Care Health Services
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP