Dislodged CatheterNCT04026906
Skin Glue to Reduce Intravenous Catheter Failure in Children
A study testing Cyanoacrylate glue and Transparent polyurethane dressing in people with Dislodged Catheter, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Dislodged Catheter
- What is being tested?
- Cyanoacrylate glue and Transparent polyurethane dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 557 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2020to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
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.
- Conditions
- Dislodged Catheter
- Being tested
- Cyanoacrylate glue, Transparent polyurethane dressing
- Keywords
- skin glue, dermabond, randomized controlled trial, intravenous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate glueDevice
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 dressingOther
The IV will be secured in the usual manner with tape and a transparent dressing.
| Study group | Role | What they receive |
|---|---|---|
| Skin Glue | Experimental | 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. Receives: Device: Cyanoacrylate glue |
| Standard Care | Placebo comparator | Patients in the control group will receive standard PIVC placement with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape. Receives: Other: Transparent polyurethane dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at the point at which the PIVC fails, up to 14 days
Secondary outcomes (4)
Time to PIVC failure
Time from PIVC insertion to failure (measured in hours)
Measured: Time from PIVC insertion to either a) PIVC failure or b) when PIVC is not longer needed for treatment, up to 14 days
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
Measured: End of study period, up to 14 days
Pain on PIVC removal as experienced by the patient or observed by the caregiver
Measured using the Visual Analogue Scale
Measured: Measured at the time of PIVC removal, up to 14 days
Difficulty of PIVC removal
measured by the bedside nurse using a 4-point Likert scale
Measured: Measured at the time of PIVC removal, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start14 Dec 2020
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dislodged CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Maala Bhatt, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026906
- Sponsor's protocol ID
- 19/09E
- Status last verified
- May 2023
- First submitted
- 11 Jul 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04026906
- Acronym / sponsor ID
- 19/09E
- Conditions
- Dislodged Catheter
- Keywords
- skin glue, dermabond, randomized controlled trial, intravenous catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Glue | Experimental | Device: Cyanoacrylate gluePatients 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. |
| Standard Care | Placebo comparator | Other: Transparent polyurethane dressingPatients in the control group will receive standard PIVC placement with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyanoacrylate glueOne drop of cyanoacrylate glue will be applied to the intravenous (IV) insertion site and another drop under the hub of the IV catheter | Device | Skin Glue |
| Transparent polyurethane dressingThe IV will be secured in the usual manner with tape and a transparent dressing. | Other | Standard Care |
Primary outcome
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.
4 secondary outcomes
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
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
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
Difficulty of PIVC removal
Time frame: Measured at the time of PIVC removal, up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanoacrylate glue and Transparent polyurethane dressing in people with Dislodged Catheter, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.