N/A
N=128
Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation
Indication for PICC Placement
Bottom Line
View on ClinicalTrials.gov: NCT02498821 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). — 176.32; 33.93 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chest X-ray (Device); Sherlock 3CG® TCS (Device); Peripherally Inserted Central Catheter (PICC) (Procedure)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). |
176.32; 33.93 | — |
| SECONDARY Total Number of Chest X-rays Performed Per Subject |
1.25; 0.03 | — |
| SECONDARY Number of Participants With Malpositions |
12; 0 | — |
| SECONDARY Number of Subsequent Malposition Attempts |
12; 0 | — |
| SECONDARY Health Care Professional (HCP) Procedural Satisfaction (Overall) |
6.22; 9.22 | — |
| SECONDARY Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use |
0; 0 | — |
| SECONDARY Number of Medication Doses Missed Due to PICC Not Being Ready for Use |
0.07; 0 | — |
| SECONDARY Number of Lab Draws Missed Due to PICC Not Being Ready for Use |
0.07; 0 | — |
| SECONDARY Number of Overtime Hours Worked Per PICC Placement Procedure |
0.07; 0 | — |
Summary
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).
Eligibility Criteria
Inclusion Criteria
- Indicated for a PICC based on institutional practices.
- Able to read and comprehend English and has signed the Informed Consent Form to participate in the study.
- PICC line is placed while a study observer is available and on the study site at the time of the placement.
Exclusion Criteria
- Infection, bacteremia, or septicemia is known or suspected.
- Body size is insufficient to accommodate the size of the implanted device.
- Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium.
- Past irradiation of prospective insertion site.
- Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
- Local tissue factors will prevent proper device stabilization and/or access.
- Under the age of 22.
- Receiving the PICC as a replacement with an over-the-wire exchange.
- Pregnant or lactating.
- Anatomical irregularities (structural and vascular of the central venous system) which may compromise catheter insertion in both the primary arm and contralateral arm.
- Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.
- Artificial heart or heart transplant.
- Anatomical abnormalities of the central venous system.
- Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
- Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.
Data sourced from ClinicalTrials.gov (NCT02498821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.