Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00742053|
Recruitment Status : Terminated (Enrollment rate was too slow.)
First Posted : August 27, 2008
Results First Posted : August 31, 2012
Last Update Posted : August 10, 2017
This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.
There is no formal study hypothesis.
|Condition or disease||Intervention/treatment||Phase|
|Primary Focus: Adult Subjects Who Require PICC Placement||Device: ECG-guided PICC placement||Not Applicable|
PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.
Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||March 2009|
Male or female inpatients, age ≥ 18 and ≤ 80 years, who are in normal sinus rhythm and do not have a pacemaker or other indwelling intracardiac device and require PICC insertion for their routine care will be studied. Intervention: ECG-guided Power PICC placement.
Device: ECG-guided PICC placement
Patients undergoing PICC placement will have ECG data collected as a function of tip location.
- Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction [ Time Frame: during catheter insertion ]In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742053
|United States, Utah|
|University of Utah Health Science Center|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Andrew D Michaels, MD||University of Utah Health Science Center|