Landmark vs. Ultrasound Guided SCVC in the ED
Status: | Terminated |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2012 |
End Date: | October 2014 |
Landmark vs. Ultrasound Guided Subclavian Central Venous Catheter Placement in the Emergency Department
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.
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.
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.
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.
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
We found this trial at
1
site
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
Click here to add this to my saved trials