Central Line Complication, Neonatal Disease
Conditions
Keywords
PICC line dressing, cyanoacrylate glue, NICU
Brief summary
This study will evaluate whether applying micro drops of cyanoacrylate glue to the participant's peripherally inserted central catheter (PICC) insertion site prior to covering the area of PICC line with a transparent film dressing will make the PICC dressing last longer and prevent an occurrence of PICC line moving out of its original placement. The investigators aims to evaluate whether 1) using the cyanoacrylate glue will lengthen the time to first dressing change; and 2) participants in the experimental arm (glue used) will have fewer dressing changes per week compared to the control arm (standard care) during admission.
Detailed description
The neonatal population poses a unique challenge due to the small surface area of PICC sites, underdeveloped skin layer, and inability to contain the child's movements during a dressing change. PICC line migration is the most common complication of PICC line maintenance in the neonatal intensive care unit (NICU). Previous studies have found that the PICC migration/dislodgment mostly occurs during PICC dressing changes among the neonatal population. Recent published studies demonstrated that medical tissue adherence glue, Cyanoacrylate, significantly reduces the incidences of catheter migration and insertion site bleeding of PICC lines in all age of patients including premature infants. The proposed study is a randomized control study with aimed data collection of 60 participants; of the 60 participants, 50 participants' data are to be used for statistical analysis and additional 10 participants to account for withdrawals. The participants will be randomly assigned to one of two groups: one (the control group) receiving our standard PICC dressing method and the other (the study group) receiving cyanoacrylate glue at the PICC insertion sites prior to applying a standard transparent film dressing over the PICC sites. The control group will reflect standard practice of PICC insertion and dressings using a standard transparent polyurethane film dressing, 3M TEGADERM Film. The study group will reflect the application of a few drops of cyanoacrylate glue, SecurePortIVTM by Adhezion Biomedical® at the insertion sites prior to dressing a PICC line area with a standard transparent polyurethane film dressing. The aim for this study is to investigate whether the application of cyanoacrylate glue at the insertion sites prior to dressing a PICC line area with a standard dressing will increase the longevity of the PICC line dressing and reduce the incidences of PICC line migration.
Interventions
DEVICECyanoacrylate glue
Adhesive to be applied on the PICC line site prior to usual standard film dressing over the site, such as SecurePortIV® Catheter Securement Adhesive by Adhezion Biomedical® Cyanoacrylate adhesive that is FDA-approved for securement of vascular access devices. Securement method that provides microbial protection by sealing the insertion site.
DEVICEStandard transparent film dressing
A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized control study
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
Inclusion criteria
* All patients admitted to the 9 North intensive coronary care unit (ICCU) at NewYork-Presbyterian Morgan Stanley Children's Hospital greater than 35 weeks of corrected gestational age who have a PICC line placed by a NICU provider.
Exclusion criteria
* Any patient with a PICC line in situ from an outside hospital. * Any patient with a PICC line placed by an outside department, namely the interventional radiology department. * Any patient with a PICC line that is silicon material catheter, such as Vygon Epicutaneo-Cava catheter because of limited accuracy of measuring a movement of the catheter migration after 25 centimeter mark due to absence of a centimeter mark on the catheter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Longevity of PICC Line Dressing | Up to 7 days | Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of PICC Line Migrations | Until PICC line removal (approximately 12 weeks) | A PICC line migration is defined as a change in the length of catheter extruding from the insertion site - a catheter migration of more than 0.25 cm will be counted. The reported values represent the total number of PICC line migrations observed across all participants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group This group will be received the current standard of care (SOC) dressing method for PICC lines. | 15 |
| Cyanoacrylate Glue Group This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site. | 17 |
| Total | 32 |
Baseline characteristics
| Characteristic | Cyanoacrylate Glue Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 7 days | 7 days | 8 days |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 17 participants | 32 participants | 15 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
Duration of Longevity of PICC Line Dressing
Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.
Time frame: Up to 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Duration of Longevity of PICC Line Dressing | 2 days |
| Cyanoacrylate Glue Group | Duration of Longevity of PICC Line Dressing | 4 days |
Secondary
Number of PICC Line Migrations
A PICC line migration is defined as a change in the length of catheter extruding from the insertion site - a catheter migration of more than 0.25 cm will be counted. The reported values represent the total number of PICC line migrations observed across all participants.
Time frame: Until PICC line removal (approximately 12 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of PICC Line Migrations | 6 PICC line migrations |
| Cyanoacrylate Glue Group | Number of PICC Line Migrations | 0 PICC line migrations |