PhlebitisNCT03193827
In-line Filtration Reduces Postoperative Phlebitis.
A study testing In-line filtration and Standard treatment in people with Phlebitis, run by Careggi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phlebitis
- What is being tested?
- In-line filtration and Standard treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 10 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old
- Consent to trial participation and randomization obtained in preoperative period
Who cannot join
- 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
About this study
Official title: In-line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: a Randomised Clinical Trial
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.
Read the 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)
- Conditions
- Phlebitis
- Being tested
- In-line filtration, Standard treatment
- Keywords
- vip score, peripheral venous cannulation, particles
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-line filtrationDevice
In-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis
Standard treatmentDevice
Patients are treated with standard intravenous solutions and vascular access management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Nov 2016
- Primary completion1 Jun 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, Careggi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193827
- Sponsor's protocol ID
- CEAV IN17/0000015
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20435946Villa 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.
PubMed 29697508
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03193827
- Acronym / sponsor ID
- CEAV IN17/0000015
- Conditions
- Phlebitis
- Keywords
- vip score, peripheral venous cannulation, particles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: In-line filtrationIn this group in-line filters (Pall, Dreieich, Germany) are connected to peripheral vascular access and used during anaesthesia and the following 96 postoperative hours. |
| control group | Active comparator | Device: Standard treatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years old
- Consent to trial participation and randomization obtained in preoperative period
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-line filtrationIn-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis | Device | study group |
| Standard treatmentPatients are treated with standard intravenous solutions and vascular access management | Device | control group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Results publication: PubMed 20435946Niel-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.
- Derived from this study: PubMed 29697508Villa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing In-line filtration and Standard treatment in people with Phlebitis, run by Careggi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.