Landmark vs. Ultrasound Guided SCVC in the ED

Hypotensive Clinical Trial

Official title:

Landmark vs. Ultrasound Guided Subclavian Central Venous Catheter Placement in the Emergency Department

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01914705
• Other study ID #: 11/12/VA01
• Status: Terminated
• Phase: N/A
• First received: July 31, 2013
• Last updated: August 7, 2015
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Placement of a central venous catheter (CVC) is a common critical care procedure performed by emergency physicians in the Emergency Department (ED.) Numerous studies have shown that physicians are able to reduce the time required, the complication rates, and the number of attempts, and to increase the overall success of CVC placement with the use of ultrasound guidance. Thus, ultrasound guided CVC placement is being increasingly utilized in the ED. The investigators propose a study to investigate the utility of ultrasound guidance for placement of subclavian CVC (SCVC) in the ED.

Currently there are numerous studies, including prospective randomized trials, comparing landmark and ultrasound guided placements of Internal Jugular(IJ) and Femoral CVC, both in the ED and in the ICU settings. However, there has not yet been a prospective randomized trial that has similarly looked at SCVC placement in the ED setting. There are a few studies looking at ultrasound guided SCVC placement performed in critical care settings, but these trials had methodological limitations. Recently, a large (401 patients), randomized, prospective study from an ICU in Greece was published in which the landmark approach was compared to ultrasound guided SCVC placement. The authors found that ultrasound guided SCVC was superior to the landmark approach in success rate, time to cannulation, and complication rates.

The investigators would like to conduct a similar prospective randomized study in the ED, in which the investigators compare the success rate, the procedural times and the complication rates between landmark and real-time ultrasound guided approaches to SCVC placement. In contrast to the recent Greek study, this study will involve a different patient population. The Greek study only looked at ventilated ICU patients, and this study will look at adult patients in the ED setting.

Once an independent clinical decision has been reached to place an SCVC by the ED attending physician, the study investigators will be contacted to enroll the patient. Patients will be randomly assigned to receive either landmark or ultrasound guided SCVC placement. In the ultrasound guidance group, a two person technique will be utilized in which the ultrasound machine will be operated by one of the investigating physicians, and the catheter will be placed by the ED physician caring for the patient. The investigators will employ real time ultrasound guidance using both the transverse and longitudinal views to help direct the needle to the vein. Once the vascular structures are identified on ultrasound by the investigating physician, the physician placing the SCVC will be directed to puncture the skin at the optimal location as determined by the investigating physician. Ultrasound will be used throughout the entire procedure to cannulate the underlying vein. In the landmark group, the SCVC will be placed using anatomic landmarks to locate the puncture site by the physicians working clinically in the ED. The Seldinger technique used for SCVC placement is the same for both the landmark and ultrasound guided approaches.

Using a stopwatch, the investigating physician will document a "Begin Time" just after the patient and the equipment have been prepped under full sterile precautions. In both groups, the timer would start at the same point in time - - when the needle is ready to puncture the skin. Complications will also be noted by the investigating physician during and after the SCVC placement, including number of puncture attempts, success/failure of blood return from the SCVC ports, occurrence of catheter tip misplacement, arterial puncture, and incidence of hematoma, hemothorax, or pneumothorax. As per routine protocol, a post-procedure chest x-ray will be obtained and will be reviewed for evidence of complications. The final Radiology Attending interpretation of the chest xray will also be recorded.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency Department Adult Patients

• Need placement of subclavian central venous catheter

Exclusion Criteria:

• Patients with known coagulopathy

• Patients with history of subclavian thrombosis

• Patients with history of vascular injury

• Pregnant females

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotensive

Intervention

Procedure:
• Landmark Procedure
Using Landmarks to guide SCVC placement
• Ultrasound Guided Procedure
Using ultrasound to guide SCVC placement

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Rate	Measure the complication rate of the physician's procedure of subclavian central venous catheter placement.	30 minutes	Yes
Primary	Success Rate	Measure whether or not the physician was able to successfully place the subclavian central venous catheter (SCVC).	30 minutes	No
Secondary	Procedure Time	Measure the time it takes the physician to perform the subclavian catheter placement procedure.	30 minutes	No