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Completed

NCT Number: NCT04026906

Skin Glue to Reduce Intravenous Catheter Failure in Children

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.

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Known allergy to skin glue, glue removal wipe, or standard catheter securement materials
  • Active infection at site of PIVC insertion
  • 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)
  • Previous enrolment in the trial
  • PIVC is expected to be used for chemotherapy (note: these are changed every 4 days even with good blood return)
  • Life-threatening or critical presentation in which consent is unable to be obtained

Treatment and study plan

Cyanoacrylate glue

Device

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

Transparent polyurethane dressing

Other

The IV will be secured in the usual manner with tape and a transparent dressing.

Primary outcomes

  1. PIVC failure before the intended intravenous treatment course is complete.

    Time frame: Measured at the point at which the PIVC fails, up to 14 days

    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.

Secondary outcomes

  1. Time to PIVC failure

    Time frame: Time from PIVC insertion to either a) PIVC failure or b) when PIVC is not longer needed for treatment, up to 14 days

    Time from PIVC insertion to failure (measured in hours)

  2. PIVC failure or removal as a result of each of the following: a) dislodgement, b) occlusion, c) infection, and d) phlebitis

    Time frame: End of study period, up to 14 days

    Numerator: number of PIVCs that fail; Denominator: Total number of PIVCs inserted

  3. Pain on PIVC removal as experienced by the patient or observed by the caregiver

    Time frame: Measured at the time of PIVC removal, up to 14 days

    Measured using the Visual Analogue Scale

  4. Difficulty of PIVC removal

    Time frame: Measured at the time of PIVC removal, up to 14 days

    measured by the bedside nurse using a 4-point Likert scale

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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