Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)

Study Overview
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Brief Summary
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Introduction: Venous access is increasingly necessary and essential in healthcare institutions, where more than 75% of hospitalised patients have some type of vascular access device cannulated. Due to their pathophysiological characteristics and pharmacological needs, some patients require special catheters, such as midline or peripherally inserted central catheters. In an attempt to reduce the main complications related to these, the safety of cyanoacrylate tissue adhesive has recently been demonstrated in the post-insertion treatment of vascular access devices. Objective: To evaluate the efficacy of the use of cyanoacrylate tissue adhesive as fixation in the post-insertion of cannulated middle and central venous catheters with modified micro-Seldinger technique in acute hospitalized patients. Methods: Randomised clinical trial with two groups(1:1): control and intervention. The control group received a cure with sutureless device plus transparent membrane and the intervention group received the same cure plus the cyanoacrylate glue. The study was approved by the Drug Research Ethics Committee of the Lleida health region. health region. KEYWORDS: Cyanoacrylates; Vascular Access Device; Catheterization, Peripheral; Nursing Care; Randomized Controlled Trial.

Detailed Description
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A randomized clinical study with two arms (control group and intervention group) was performed. Patients were selected according to whether they met the inclusion/exclusion criteria and all patients who met the criteria were offered to participate on a voluntary basis. These were collected by the intravenous therapy team (ETI) of the Arnau de Vilanova University Hospital (HUAV) in Lleida, from September 16, 2020 until the completion of the collection of the total number of patients required for the study (n=216). Patients required insertion of a midline venous catheter (BD-18580 PowerMidline™ 4F) or a peripherally inserted central catheter (BD-20178 PowerPICC™ 4,5 or 6 F), according to the ETI-HUAV algorithm. All insertions were performed with the aid of ultrasound as a guiding technique. In addition, all patients underwent dermatotomy during the technique and the application of a post-insertion hemostasis protocol for at least 2 minutes or until the insertion site stopped bleeding, in order to unify the researchers' criteria. After insertion of the vascular access device, the control group underwent the standard dressing: transparent polyurethane dressing with reinforced edge (3M®-1655 Tegaderm™ IV) and Sutureless Fixation Device (BD-19940 StatLock™ PICC Plus); and the intervention group, the standard dressing plus application of cyanoacrylate tissue adhesive (SP-015V SecurePortIV™ from Adhezion Biomedical, Llc.). Afterwards, 3 scheduled cures were performed, at 24 hours, 72 hours and 7 days post-insertion, looking for the main complications: bleeding and/or pericatheter exudate, catheter displacement, signs of phlebitis and catheter-related pain.

Official Title
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Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)

Conditions
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Vascular Access Device, Catheterization, Peripheral, Nursing Care, Randomized Controlled Trial

Intervention / Treatment
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* Procedure: cyanoacrylate adhesive (SecurePortIV®)
* Procedure: standard cure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age requiring cannulation of a midline catheter (BD-18580 PowerMidline™ 4F) or a PICC (BD-20178 PowerPICC™ 4.5 or 6 F) who accepted and signed the informed consent voluntarily with an inpatient unit admission of minimum 7 days Exclusion Criteria: patients with skin conditions contraindicating the application of a skin glue or known allergy to cyanoacrylate, as recorded in the clinical history

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Classical parallel model with an intervention group, to which cyanoacrylate tissue adhesive was applied, and a control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>After cannulation of a midline catheter or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care. | Procedure: standard cure<br>* The standard cure consists of: Application of hemostasis at the point of insertion for 2 minutes post puncture or until bleeding stops. Fix with clear polyurethane dressing (3M®-1655 Tegaderm™ IV) and sutureless fixation device (BD-19940 StatLock™ PICC Plus).<br>|
| Experimental: Intervention<br>After cannulation of a midline catheter or peripherally inserted central venous catheter with a modified micro-Seldinger technique, the intervention group underwent the standard treatment plus application of cyanoacrylate tissue adhesive (SecurePortIV®) at the puncture site. | Procedure: cyanoacrylate adhesive (SecurePortIV®)<br>* Application of cyanoacrylate tissue adhesive (SecurePortIV®) to the puncture site plus standard wound care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Percentage of participants with adverse events after being treated with cyanoacrylate tissue adhesive at the puncture site after insertion of cannulated middle and central venous catheters with the modified micro-Seldinger technique. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with post-treatment hemorrhage assessed by observation (yes/no). | Percentage of participants with pericatheter bleeding after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized for signs of bleeding and it will be noted whether there is bleeding or not. | 7 days | 
| Number of participants with post-treatment catheter displacement assessed by observation (yes/no). | Percentage of participants with catheter displacement after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check if the catheter is still in the same point or if it has been displaced. | 7 days | 
| Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale. | Percentage of participants with phlebitis after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check for signs of phlebitis, according to the Maddox scale. | 7 days | 
| Number of participants with post-treatment pain in extremity assessed with the EVA scale. | Percentage of participants with pain in extremity after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the patient will be asked what pain he/she feels in the extremity related to the catheter. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyanoacrylates, Cyanoacrylate, Tissue adhesive