Primary Focus: Adult Subjects Who Require PICC Placement
Conditions
Keywords
ECG PICC, Patients undergoing PICC placement
Brief summary
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.
Detailed description
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.
Interventions
DEVICEECG-guided PICC placement
Patients undergoing PICC placement will have ECG data collected as a function of tip location.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Require Power PICC placement as standard care * Signed informed consent
Exclusion criteria
* Has an intracardiac device * Does not have normal sinus rhythm * Has known abnormality of central venous system * Plasma creatinine \>=1.5 mg/dL * Pregnancy * Allergy or prior reaction to contrast material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at the University of Utah between August 2008 and December 2008.
Participants by arm
| Arm | Count |
|---|---|
| PICC Insertion All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | PICC Insertion |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 58.86 years STANDARD_DEVIATION 15.48 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction
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.
Time frame: during catheter insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PICC Placement | Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction | 0.5 cm | Standard Deviation 1.2 |