Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04086693 |
Other study ID # |
2019-188 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 16, 2019 |
Est. completion date |
October 10, 2020 |
Study information
Verified date |
December 2021 |
Source |
William Beaumont Hospitals |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This clinical trial will compare survival of peripheral intravenous (IV) catheters for
patients with a standard IV site dressing alone to patients with standard IV dressing plus
Adhezion Biomedical SecurePortIV Catheter Securement Adhesive. Emergency room patients who
already have IVs may be considered for inclusion. Eligible patients will be approached and,
if they are interested in participating, their informed consent will be obtained.
Participation will continue for up to 7 days. During this time, the patient will experience:
- Assessment of their currently placed peripheral IV catheter, to assess if it is
functioning
- Assignment to one of two study groups (standard IV dressing or standard IV dressing plus
Adhezion Biomedical SecurePortIV Catheter Securement Adhesive). This is called
randomization and group assignment is by chance, like the flip of a coin
- Daily assessment of the IV catheter and site for complications (such as infection or
phlebitis), removal, and medications being administered.
Description:
Patients admitted from the Emergency Department (ED) to a progressive floor, or patients
admitted from ED to any floor type with express approval from the Principal Investigator are
eligible participants. Research staff will approach patients admitted to the progressive
floors (or other floors when identified by PI) based on screening of the electronic medical
record. These patients are approached by research staff when physically in the emergency
department waiting for a room assignment. If the patient agrees to participate in the trial,
the study subject will approached for consent by the research staff. Research staff will
confirm functionality of the existing peripheral IV previously placed by ED staff. The
assessment will include observing for blood return into the tubing upon aspiration and/or
unobstructed flush with a minimum of 1-2 ml of normal saline. Staff will also observe the
site for any signs of redness or tenderness. A tourniquet may be applied as needed. If the
patient is actively receiving an infusion, the drip will briefly be halted to evaluate for
functionality. Functionality will be assessed with the existing dressing in place. If the
catheter is functional and free of any signs of complications, study subjects will be
randomized by a computer generated 1:1 envelope system to either the control group:
polyurethane dressing + clear tape or the experimental group: polyurethane dressing + clear
tape + tissue adhesive. The tissue adhesive is not standard of care at Beaumont. For the
control group, the polyurethane dressing will be gently removed. Dressing will be removed
carefully to minimize any potential dislodgments or skin injury. The site will be evaluated
for oozing or blood and as needed cleaned with sterile gauze. Once the site is completely
dry, a new polyurethane dressing will be applied and reinforced with tape in a standard
fashion. Once securement is complete, functionality will be reassessed per protocol above.
For the experimental group, the existing securement will be gently removed. There are not
special steps required for removing the dressing with the tissue adhesive. The IV catheter is
secured and the dressing is removed gently. The site will be evaluated for oozing or blood
and as needed cleaned with sterile gauze. Once the site is completely dry, the tissue
adhesive will be applied. A new standard polyurethane dressing will be applied and tape will
be applied per the standard approach. Once securement is complete, functionality will be
reassessed. The time of the new dressing application will be noted as time zero. Catheter
dwell time will begin at this point. Additional data variables collected at the initial
assessment include: demographics such as age, sex, international normalized ratio (INR) >1.5,
platelets < 50, insertion site details, hours from insertion to recruitment, inserter
credentials.
Follow-up Assessment:
After initial assessment, the catheter will be assessed by the research team every 24 hours
as long as the patient is hospitalized up to 7 days or 168 hours. At each follow up interval
the researcher notes the date /time of evaluation and assesses for any signs and symptoms of
complications and functionality of the device. A catheter is functional if the IV flushes
without resistance. Complications include infiltration, phlebitis, dislodgement, oozing
fluid/blood, purulent drainage, or occlusion. Catheters will be assessed daily for signs and
symptoms of complications. Any signs or symptoms of complications or lack of functionality
will be reported to the patient's primary care team so that management of the IV catheter can
be addressed. If the catheter was identified to have any signs or symptoms of complications
during follow-up assessment the date and time of observation of the complication will be
documented in the data collection tool and the primary team will be notified of the
complication. If the catheter was removed prior to the follow-up assessment then the IV
removal time and the reason for removal will be obtained through chart review. For all
catheters removed due to a complication, re-insertion attempt data will be tracked through
the medical record in the nursing section for venous lines and need for reinsertion of the IV
or escalation to a midline, peripherally inserted central catheter (PICC), or central venous
catheter (CVC) will be noted. If the patient is discharged prior to the time of follow-up
assessment then the time of discharge will be documented and the IV will be presumed
functional until time of discharge unless otherwise noted in the chart.
The medication administration record will be queried for all medications given through each
catheter with specific attention to antibiotics and anticoagulants. Vesicants/irritants that
are generally given via central line or considered caustic to the vessel will be noted in
both groups. Number of doses will be recorded. Additional data gathered by research staff on
follow-up evaluation includes: dwell time in days/hours, hospital length of stay, and number
of peripheral IVs for duration of stay.