Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax? - Full Text View

Sponsor:	Christiana Care Health Services
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00388375

Purpose

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.

Condition	Intervention
Catheterization, Central Venous	Procedure: Ultrasound

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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?

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Time needed to complete the US exam and CXR [ Time Frame: varies ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388375

Locations

United States, Delaware
Christiana Care Heath System
Newark, Delaware, United States, 19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator:

Jason Nomura, MD

Christiana Care Health Services

More Information

No publications provided

Responsible Party:	Christiana Care Health Services ( Paul Sierzenski, MD, RDMS )
Study ID Numbers:	25185
Study First Received:	October 12, 2006
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00388375 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Respiratory Tract Diseases
Pleural Diseases
Pneumothorax

ClinicalTrials.gov processed this record on November 27, 2009