Clinical trial NCT04026906: Skin Glue to Reduce Intravenous Catheter Failure in Children
Official title: Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dislodged Catheter
Keywords: skin glue
dermabond
randomized controlled trial
intravenous catheter
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2019-07-19
Enrollment: 557
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intravenous (IV) catheter placement is the most common medical procedure in emergency department settings. IVs are used to deliver medications, fluids and blood products to patients. At the Children's Hospital of Eastern Ontario, approximately three-quarters of children admitted to hospital have an IV inserted while they are in the emergency department. However, a challenge associated with IVs is that they sometimes stop working or fall out before treatment has been completed (this is known as IV failure). When IVs fail, a new IV often needs to be placed. Children rank IV placement as one of the leading causes of pain in the hospital setting. The investigators are interested in understanding whether there are strategies that can help keep IVs in place longer for children admitted to hospital.

Previous studies investigating whether certain types of bandages over IV sites are helpful in keeping IVs in longer found all bandages performed about the same. However, a recent study of adult patients showed that using medical-grade skin glue to secure the IV significantly reduced IV failure rates when compared to usual care. There have been no similar studies in children. The objective of this study is to understand whether placement of skin glue at IV insertion sites is effective in decreasing IV failure rates in children. This study will take place in the emergency department at Children's Hospital of Eastern Ontario (CHEO). Consenting children will be randomly assigned to receive IV placement either with or without skin glue (one drop at the IV insertion site and another drop under the hub of the catheter), along with otherwise standard securement with a transparent dressing. The investigators will look at the numbers of children in each group whose IVs fail before their intended treatment course is complete. This study has the potential to improve patient and family satisfaction, decrease nursing workload and reduce healthcare costs.


Eligibility criteria: Inclusion Criteria:

1. Age 0 days to 18 years
2. Patient must require a PIVC as part of their management plan
3. Patient must be physically in the ED at the time of PIVC insertion

Exclusion Criteria:

1. At the time of insertion, the treating physician anticipates the patient will likely be discharged from the ED (with or without the PIVC in place)
2. Known allergy to skin glue, glue removal wipe, or standard catheter securement materials
3. Active infection at site of PIVC insertion
4. Insurmountable language barrier (patient's parent/guardian is unable to understand English or French well enough to give informed consent and participate in follow-up)
5. Previous enrolment in the trial
6. PIVC is expected to be used for chemotherapy (note: these are changed every 4 days even with good blood return)
7. Life-threatening or critical presentation in which consent is unable to be obtained

Primary outcomes:
measure: PIVC failure before the intended intravenous treatment course is complete.
timeFrame: Measured at the point at which the PIVC fails, up to 14 days
Secondary outcomes:
measure: Time to PIVC failure
timeFrame: Time from PIVC insertion to either a) PIVC failure or b) when PIVC is not longer needed for treatment, up to 14 days
measure: PIVC failure or removal as a result of each of the following: a) dislodgement, b) occlusion, c) infection, and d) phlebitis
timeFrame: End of study period, up to 14 days
measure: Pain on PIVC removal as experienced by the patient or observed by the caregiver
timeFrame: Measured at the time of PIVC removal, up to 14 days
measure: Difficulty of PIVC removal
timeFrame: Measured at the time of PIVC removal, up to 14 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital Of Eastern Ontario
state: Ontario
Study officials:
References: