Randomized Controlled Trial Clinical Trial
— CIANO-ETIOfficial title:
Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
Verified date | September 2022 |
Source | Hospital Arnau de Vilanova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 216 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Arnau de Vilanova | Lleida | Cataluña |
Lead Sponsor | Collaborator |
---|---|
Hospital Arnau de Vilanova |
Spain,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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