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

Hospital Arnau de Vilanova

Status: Completed

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

Treatments: Procedure: standard cure; Procedure: cyanoacrylate adhesive (SecurePortIV®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05299060

01-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups

Control

Active Comparator group

Description:

After cannulation of a midline catheter or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.

Treatment:

Procedure: standard cure

Intervention

Experimental group

Description:

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.

Treatment:

Procedure: cyanoacrylate adhesive (SecurePortIV®)