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

Catheterization, Central Venous Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00388375
• Other study ID #: 25185
• Status: Terminated
• Phase: N/A
• First received: October 12, 2006
• Last updated: October 17, 2014
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Catheterization, Central Venous
• Pneumothorax

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Heath System	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence or absence of a misplaced CVC as detected by US and CXR.		10 Minutes	Yes
Primary	The presence or absence of PTX as detected by US and CXR		10 minutes	No
Secondary	Time needed to complete the US exam and CXR		varies	No