Skin Glue to Reduce Intravenous Catheter Failure in Children

Dislodged Catheter Clinical Trial

Official title:

Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026906
• Other study ID #: 19/09E
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: April 12, 2023

Study information

• Verified date: May 2023
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dislodged Catheter

Intervention

Device:
• Cyanoacrylate glue
One drop of cyanoacrylate glue will be applied to the intravenous (IV) insertion site and another drop under the hub of the IV catheter

Other:
• Transparent polyurethane dressing
The IV will be secured in the usual manner with tape and a transparent dressing.

Locations

Country	Name	City	State
Canada	Children's Hospital Of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PIVC failure before the intended intravenous treatment course is complete.	PIVC failure is defined by a composite of dislodgement, occlusion, signs of infection, and phlebitis. Dislodgement is defined as subcutaneous extravasation, accidental removal by patient or staff, or history that the PIVC "fell out". Occlusion is defined as an inability to flush the catheter with 2-3ccs of normal saline or history that the PIVC was "not working". Infection is defined as presence of pus, erythema, pain, and/or swelling around the PIVC site in keeping with a clinical suspicion of infection or cellulitis. Phlebitis is defined as a painful, palpable, cord-like vein.If the PIVC fails (as per the above definition) before an order is written to discontinue the PIVC, it will be determined the device failed before the treatment course was complete.	Measured at the point at which the PIVC fails, up to 14 days
Secondary	Time to PIVC failure	Time from PIVC insertion to failure (measured in hours)	Time from PIVC insertion to either a) PIVC failure or b) when PIVC is not longer needed for treatment, up to 14 days
Secondary	PIVC failure or removal as a result of each of the following: a) dislodgement, b) occlusion, c) infection, and d) phlebitis	Numerator: number of PIVCs that fail; Denominator: Total number of PIVCs inserted	End of study period, up to 14 days
Secondary	Pain on PIVC removal as experienced by the patient or observed by the caregiver	Measured using the Visual Analogue Scale	Measured at the time of PIVC removal, up to 14 days
Secondary	Difficulty of PIVC removal	measured by the bedside nurse using a 4-point Likert scale	Measured at the time of PIVC removal, up to 14 days