In-line Filtration Reduces Postoperative Phlebitis.

NCT03193827 | Completed

• 1 other identifier: CEAV IN17/0000015
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access. In this controlled trial, 268 surgical patients are 1:1 randomised to in-line filtration (study group) and standard care (control group). The incidence of phlebitis (defined as Visual Infusion Phlebitis, VIP score≥2) within 48hrs postoperatively is compared between the two groups, as well as the onset and severity of phlebitis and the reasons for removal of the cannula. The lifespan of venous cannulae and cost-of-care are compared for the study and control groups through a Kaplan-Meier curve. Multivariate Cox regression analysis is performed to evaluate the effect of in-line filtration on risk of phlebitis and cannula removal.

Conditions

Phlebitis

Keywords

vip score; peripheral venous cannulation; particles

Outcome Measures

Primary Outcomes (1)

• The aim of the trial is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access in the 48 postoperative hours

  The incidence of phlebitis is evaluated through Visual Infusion Phlebitis (VIP) score.Phlebitis is defined as a VIP score ≥ 2. A Fischer's exact test will be use to evaluate difference between study group and control group.

  VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively

Secondary Outcomes (3)

• A secondary objective is to evaluate difference between study group and control group phlebitis onset in the 96 postoperative hours

  VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively

• A secondary objective is to show difference between study group and control group phlebitis severity in the 96 postoperative hours

  VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively

• A secondary objective is to evaluate care cost increase secondary to in-line filtration management between study group and control group

  In 96 postoperative hours, all materials used (infusion sets, vascular dressing devices, filters, kit for venipuncture...) to manage vascular access in control group and in study group is registered

Study Arms (2)

study group

EXPERIMENTAL

In this group in-line filters (Pall, Dreieich, Germany) are connected to peripheral vascular access and used during anaesthesia and the following 96 postoperative hours.

Device: In-line filtration

control group

ACTIVE COMPARATOR

Patients randomised to standard care are managed without an in-line filter and according to local routine practice for intravenous drug administration in the adult patient.

Device: Standard treatment

Interventions

In-line filtration DEVICE

In-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis

study group

Standard treatment DEVICE

Patients are treated with standard intravenous solutions and vascular access management

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• Consent to trial participation and randomization obtained in preoperative period

You may not qualify if:

• Pregnancy
• Presence of central vascular access with central or peripheral iserction
• Presence of long peripheral vascular access such as Midline or MiniMidline
• Patients envolved in other comparative trial

Sponsors & Collaborators

• Careggi Hospital: lead

Related Publications (2)

• Niel-Weise BS, Stijnen T, van den Broek PJ. Should in-line filters be used in peripheral intravenous catheters to prevent infusion-related phlebitis? A systematic review of randomized controlled trials. Anesth Analg. 2010 Jun 1;110(6):1624-9. doi: 10.1213/ANE.0b013e3181da8342. Epub 2010 Apr 30.

  PMID: 20435946 RESULT

• Villa G, Chelazzi C, Giua R, Tofani L, Zagli G, Boninsegni P, Pinelli F, De Gaudio AR, Romagnoli S. In-Line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: A Randomized Clinical Trial. Anesth Analg. 2018 Dec;127(6):1367-1374. doi: 10.1213/ANE.0000000000003393.

  PMID: 29697508 DERIVED

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Two hundred and sixty-eight patients undergoing surgery are randomised 1:1 to in-line filtration (study group) and standard care (control group). For patients randomize to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used during anaesthesia and the following 96 postoperative hours. Patients randomize to standard care (control group) are managed without an in-line filter and according to local routine practice for intravenous drug administration in the adult patient. The incidence and severity of phlebitis are evaluated using the Visual Infusion Phlebitis (VIP) Score23 every 12 hrs from the end of surgery until 96 hrs postoperatively in both groups. Time and severity of phlebitis and time and causes for venous cannula removal are all compared between groups.

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 21, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 10, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share