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出境医 / 临床实验 / Skin Glue to Reduce Intravenous Catheter Failure in Children

Skin Glue to Reduce Intravenous Catheter Failure in Children

Study Description
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.


Condition or disease Intervention/treatment Phase
Dislodged Catheter Device: Cyanoacrylate glue Other: Transparent polyurethane dressing Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Skin Glue
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.
 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
Placebo Comparator: Standard Care
Patients in the control group will receive standard PIVC placement with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape.
 Other: Transparent polyurethane dressing
The IV will be secured in the usual manner with tape and a transparent dressing.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of PIVCs that fail 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 Outcome Measures :
  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. The proportion of PIVCs that fail or are removed as a result of 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; Measured with a pictogram with faces but attached to a score of 0 to 5 (5 representing the most pain)

  4. Difficulty of PIVC removal [ Time Frame: Measured at the time of PIVC removal, up to 14 days ]
    Measured on a 5 point Likert scale (range: 0 to 5, 5 representing the most difficulty)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must require a PIVC as part of their management plan
  • Patient must be physically in the emergency department at the time of PIVC insertion

Exclusion Criteria:

  • At the time of insertion, PIVC is expected to be removed in less than 12 hours (procedural sedation, migraine treatment, etc.)
  • Known allergy to skin glue, glue removal solution, or standard catheter securement materials
  • infection at site of PIVC insertionInsurmountable language barrier (patient's parent/guardian is unable to understand English or French well enough to give informed consent and participate in follow-up)
  • enrolment in the trial
  • At time of insertion, the management plan is for the patient to be discharged home with the PIVC in place
  • PIVC is being 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tyrus Crawford 6137377600 ext 4178 tcrawford@cheo.on.ca
Contact: Candice McGahern 6137600 ext 4111 cmcgahern@cheo.on.ca

Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		Percentage of PIVCs that fail 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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)
  • The proportion of PIVCs that fail or are removed as a result of 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
  • 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; Measured with a pictogram with faces but attached to a score of 0 to 5 (5 representing the most pain)
  • Difficulty of PIVC removal [ Time Frame: Measured at the time of PIVC removal, up to 14 days ]
    Measured on a 5 point Likert scale (range: 0 to 5, 5 representing the most difficulty)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skin Glue to Reduce Intravenous Catheter Failure in Children
Official Title  ICMJE Skin Glue to Reduce Peripheral Intravenous Catheter Failure Rate in Children: A Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dislodged Catheter
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Skin Glue
    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.
    Intervention: Device: Cyanoacrylate glue
  • Placebo Comparator: Standard Care
    Patients in the control group will receive standard PIVC placement with cloth-bordered transparent polyurethane dressing (Tegaderm® I.V. Advanced) and tape.
    Intervention: Other: Transparent polyurethane dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019) 		556
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must require a PIVC as part of their management plan
  • Patient must be physically in the emergency department at the time of PIVC insertion

Exclusion Criteria:

  • At the time of insertion, PIVC is expected to be removed in less than 12 hours (procedural sedation, migraine treatment, etc.)
  • Known allergy to skin glue, glue removal solution, or standard catheter securement materials
  • infection at site of PIVC insertionInsurmountable language barrier (patient's parent/guardian is unable to understand English or French well enough to give informed consent and participate in follow-up)
  • enrolment in the trial
  • At time of insertion, the management plan is for the patient to be discharged home with the PIVC in place
  • PIVC is being 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tyrus Crawford 6137377600 ext 4178 tcrawford@cheo.on.ca
Contact: Candice McGahern 6137600 ext 4111 cmcgahern@cheo.on.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026906
Other Study ID Numbers  ICMJE 19/09E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maala Bhatt, Children's Hospital of Eastern Ontario
Study Sponsor  ICMJE Children's Hospital of Eastern Ontario
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Children's Hospital of Eastern Ontario
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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