Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

In-line Filtration Reduces Postoperative Phlebitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193827
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Gianluca Villa, Careggi Hospital

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.


Condition or disease Intervention/treatment Phase
Phlebitis Device: In-line filtration Device: Standard treatment Not Applicable

Detailed Description:

A randomised, controlled, clinical trial is performed at the Department of Anesthesia and Intensive Care of the Azienda Ospedaliero-Universitaria Careggi in Florence, Italy, to assess the effects of in-line filtration on the incidence of postoperative phlebitis. The Ethical Committee of the institution has approved the study (CEAV IN17/0000015). Patients preoperatively sign consent forms for participation in this trial.

An incidence of phlebitis equal to 50% within 48 hrs from peripheral venous cannulation has been preliminarily described in our centre during standard care (unpublished data). Two hundred and sixty-eight patients undergoing surgery are 1:1 randomised to in-line filtration (study group) and standard care (control group) to observe a 20% reduction in postoperative phlebitis within 48 hrs after surgery in the study group through a one-side chi-square analysis with statistical power of 90% and statistical significance of 0.025.

Every surgical patient scheduled for surgery, who preoperatively signed the consent form and underwent peripheral venous cannulation, is considered for this study. Patients undergoing central venous catheterisation or long-/middle-term peripheral cannulation are excluded.

On the day of surgery, all enrolled patients undergo standard peripheral venous cannulation according to the up-to-date standard of care. After placement of venous cannula and before the induction of anaesthesia, patients are randomised for in-line filtration or standard care.

For patients randomized to in-line filtration, in-line filters (Pall, Dreieich, Germany) are used during anaesthesia and the following 96 postoperative hours.

Patients randomised 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 enrolment in this study don't influence the type of anaesthesia or the postoperative pharmacological treatment previously scheduled for the patient.

The incidence and severity of phlebitis are evaluated using the Visual Infusion Phlebitis (VIP) Score every 12 hrs from the end of surgery until 96 hrs postoperatively. The postoperative VIP score evaluations are performed by another author, blinded to each patient's randomisation group. This filter are held by containment bands on the patient's arm and are completely covered by a breathable dressing medication to maintain the evaluator blind on the patient's randomisation group. The dressing medication never covers the vein where the cannulae are placed. Transparent dressing is used for cannula medication to allow cannulation site inspection

Phlebitis is defined as a VIP score ≥2. The primary end-point of the study is to assess the incidence of phlebitis in the 48 postoperative hours using a Fisher's exact test. Time and severity of phlebitis and time and causes for venous cannula removal are all compared between groups. In particular, data distribution is assessed through the Shapiro-Wilk test. Continuous data are presented as a median and interquartile range (IQR) or mean ± standard deviation (SD) and analysed through a Mann-Whitney or Student's t-test, according to data distribution. Qualitative data are presented as percentages and analysed through chi-square analysis. The Bonferroni adjustment is used for multiple comparisons. The lifespan of the cannulae is described for the study and the control groups through the Kaplan-Meier curve. Multivariate Cox regression analysis with a backwards selection is performed to evaluate the effect of in-line filtration on the risk of phlebitis and cannula removal, independently from other factors. Results are presented as p-value, hazard ratio (HR) and 95% confident interval (95%CI)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: In-line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: a Randomised Clinical Trial
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 10, 2017

Arm Intervention/treatment
Experimental: study group
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
In-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis

Active Comparator: control group
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
Patients are treated with standard intravenous solutions and vascular access management




Primary Outcome Measures :
  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 [ Time Frame: VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively ]
    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.


Secondary Outcome Measures :
  1. A secondary objective is to evaluate difference between study group and control group phlebitis onset in the 96 postoperative hours [ Time Frame: VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively ]
    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.

  2. A secondary objective is to show difference between study group and control group phlebitis severity in the 96 postoperative hours [ Time Frame: VIP score is evaluated every 12hrs from the end of surgery until 96 hrs postoperatively ]
    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.

  3. A secondary objective is to evaluate care cost increase secondary to in-line filtration management between study group and control group [ Time Frame: 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 ]
    Care cost is calculated through evaluation of intravenous treatment expenditure in control group and study group. In both group is calculated the costs of the disposables used and the costs of the time spent by the staff involved in the management of peripheral venous access during the first 96 hours postoperatively. In these evaluation we consider: frequency of infusion set substitutions and all devices used; frequency of vascular access replacement, alla devices used to replace a new cannulae and caregiver cost related to time needed to replacement and cost for hours of nursing, medical or anesthesiological work.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gianluca Villa, MD, Careggi Hospital
ClinicalTrials.gov Identifier: NCT03193827     History of Changes
Other Study ID Numbers: CEAV IN17/0000015
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gianluca Villa, Careggi Hospital:
vip score
peripheral venous cannulation
particles

Additional relevant MeSH terms:
Layout table for MeSH terms
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis