Skin Glue to Reduce Intravenous Catheter Failure in Children

Children's Hospital of Eastern Ontario

Status: Completed

Conditions: Dislodged Catheter

Treatments: Other: Transparent polyurethane dressing; Device: Cyanoacrylate glue

Study type: Interventional

Funder types: Other

Identifiers

NCT04026906

19/09E

Details and patient eligibility

About

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.

Enrollment: 557 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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557 participants in 2 patient groups, including a placebo group

Skin Glue

Experimental group

Description:

Patients in the intervention group will receive standard peripheral intravenous catheter (PIVC) securement (with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape). In addition they will receive a drop of cyanoacrylate glue (Dermabond® topical skin adhesive) at both the PIVC insertion site and under the hub of the catheter.

Treatment:

Device: Cyanoacrylate glue

Standard Care

Placebo Comparator group

Description:

Patients in the control group will receive standard PIVC placement with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape.

Treatment:

Other: Transparent polyurethane dressing