PhlebitisResPeCtNCT02568670
Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study
A study testing clinical signs in people with Phlebitis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This is a two-centers, open label, prospective, randomized, noninferiority controlled trial with cost-effectiveness analysis to verify if is non inferior to remove peripheral intravenous catheter according to clinical signs in relation to every 96 hours. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phlebitis
- What is being tested?
- clinical signs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,305 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any medical diagnosis, except for those stated as exclusion criteria, and
- with a therapeutic proposal of undergoing the therapy for at least 96 hours, or four days;
- agree with the proposals expressed in the Informed Consent Form (ICF); and
- have a catheter that has not been placed at the ER.
Who cannot join
- medical diagnosis of immunosuppression or receiving immunosuppressants;
- using more than one peripheral catheter simultaneously;
- refusing to take part in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)
This is a two-centers, open label, prospective, randomized, noninferiority controlled trial with cost-effectiveness analysis to verify if is non inferior to remove peripheral intravenous catheter according to clinical signs in relation to every 96 hours.
Read the detailed description
The care practice standards related to infusion therapy (IT) are stipulated and regulated by US institutions, such as the Infusion Nurses Society (INS) and the Center for Disease and Control (CDC), and, in Brazil, by the Brazilian National Health Surveillance Agency (ANVISA). Within this topic, the investigators can mention peripherally administered IT through peripheral intravenous catheters (PIC) as the most used one, since this is less complex and less invasive, and it offers a lower risk of severe complications compared to central line IT.
PIC placement, maintenance and removal procedures are not free of complications, and in order to prevent them, regulatory agencies publish formal recommendations. One of these refers to the time the PIC remains at the same site (residence time), which has been determined to be 96 hours for the adult population, i.e., it should be removed and punctured again at another site, systematically, even if not showing any inflammatory sign within 96 hours.
Following literature review, one can see that these recommendations are based on limited evidence, and supported by data from old studies. For this reason, the investigators discuss if employing a systematic and elective change procedure for adults would be the best option, as the investigators have taken some aspects into consideration, such as: Patient safety - The PIC dwell time at the placement site, as shown by research results, has increased throughout the decades to 24, 48, 72, and 96 hours. If the PIC change is performed on a child who, theoretically, is a less immune-competent patient as compared to adults, this is performed according to clinical signs, then the investigators can conclude that adopting the same procedure for adults would be safe. Peripheral venous depletion - Logic leads us to consider that the less the investigators puncture a patient, more access is available, and less outcomes with IT-specific complications occur. Patient satisfaction - With reduced exposures to painful and invasive events, the patient will also benefit from it. Few patients refrain from showing dissatisfaction when the PIC is to be placed again electively. Quality - Producing scientific evidence and adopting the best practices in hospital environments is practicing quality. Economic aspects - If these PIC changes were less frequent, they would necessarily imply less spending with inputs and devices, as well as less time spent by the team performing the procedure, which represents less cost and workload. Occupational safety - Studies show an estimated relationship between the occurrence of an accident with biological material and performing invasive procedures. Reducing the number of punctures performed by a professional, in addition to decreasing the workload, may reduce the exposure to risk and accidents.
Research studies carried out mostly in Australia aim at showing that the systematic PIC removal and change do not bring benefits, when compared to change based on clinical manifestations. However, a systematic review study in 2010 did not find conclusive evidence, and suggested the development of other projects in several regions, of different natures and realities, so as to further mature the hypothesis. To support this, the INS has also formally stated that this theme is a research priority at this time.
- Conditions
- Phlebitis
- Being tested
- clinical signs
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical signsOther
to remove the peripheral venous catheter according clinical signs
| Study group | Role | What they receive |
|---|---|---|
| according to clinical signs | Experimental | removal the peripheral catheter according to clinical signs Receives: Other: clinical signs |
| sistematically every 96 hours | No intervention | removal the peripheral catheter every 96 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of phlebitis
phlebitis (phlebitis/1000 peripheral venous catheters-day), stratified by severity.
Measured: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
Secondary outcomes (5)
presence of other complications related peripheral intravenous (PIC) therapy in the two groups
complications (event/1000 peripheral venous catheters-day)
Measured: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
time interval for peripheral intravenous catheter (PIC) changes
Through these measures:
- length of stay in hours / avp-day * 1000
- length of stay in hours / patient
From catheter fixation, during the indwell time of the catheter, until the removal of it.
Measured: For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
total number of peripheral intravenous catheter (PIC)
Total number of peripheral intravenous catheter (PIC) used in the two groups. Through these measures:
- number of PIC re-inserted / patient
- number of PIC re-inserted / avp-day * 1000
- number of venous punctures to obtain access / patient
Measured: After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days
Cost
. Cost of 30 minutes of professional time for peripheral intravenous puncturing (PIP).
- Cost of inputs for each insertion - soap for cleaning, examination gloves, pre-filled syringe with saline, alcohol swab, PIC, intermediate type extension y, two valve connectors, fixture and transparent semi-permeable membrane covering polyurethane.
- Cost 10 minutes from time professional (practical nurse) for removal.
- Cost of inputs to remove the PIC - alcohol swab and anti-hemorrhagic coverage.
- Cost of daily patient hospitalization related to the catheter dwell time.
Measured: during the hospitalization, in average 5 to 6 days
The experience of the patient
applying a questionnaire of assessment of the experience of the patient in use of peripheral venous catheter at the end of admission, wich was elaborated by the author and validated by expert judges. Principal contents: Information and education: guidance on research and care given peripheral IT Physical comfort: pain or discomfort procedures Emotional support: considered in this study as trust / security transmitted and perceived Respect for patient preferences: flexibility to accept small patient preferences Involvement of family and friends: identify the participation of people significant to patient and allow shared decision Continuity and transition: if care is independent continuous service location within the institution General impressions: courtesy and availability of staff Overall satisfaction: at the end the experience was satisfying Complaints: originated by dissatisfaction reasons Fidelity: creation of the trust, return and referral to another service
Measured: the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- None (open label)
- Enrolment
- 1,305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Vendramim, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568670
- Sponsor's protocol ID
- 15849513.2.0000.5487
- Acronym
- ResPeCt
- Status last verified
- Mar 2018
- First submitted
- 21 Sep 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vendramim P, Avelar AFM, Rickard CM, Pedreira MDLG. The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 hours: A randomized, controlled, non-inferiority trial. Int J Nurs Stud. 2020 Jul;107:103504. doi: 10.1016/j.ijnurstu.2019.103504. Epub 2020 Jan 11.
PubMed 32334176
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal Peripheral Intravenous Catheters According to Clinical Signs or Every 96 Hours: A Non Inferiority Study (ResPeCt)
- ClinicalTrials.gov ID
- NCT02568670
- Acronym / sponsor ID
- ResPeCt / 15849513.2.0000.5487
- Conditions
- Phlebitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,305 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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.
This is a two-centers, open label, prospective, randomized, noninferiority controlled trial with cost-effectiveness analysis to verify if is non inferior to remove peripheral intravenous catheter according to clinical signs in relation to every 96 hours.
Detailed description
The care practice standards related to infusion therapy (IT) are stipulated and regulated by US institutions, such as the Infusion Nurses Society (INS) and the Center for Disease and Control (CDC), and, in Brazil, by the Brazilian National Health Surveillance Agency (ANVISA). Within this topic, the investigators can mention peripherally administered IT through peripheral intravenous catheters (PIC) as the most used one, since this is less complex and less invasive, and it offers a lower risk of severe complications compared to central line IT.
PIC placement, maintenance and removal procedures are not free of complications, and in order to prevent them, regulatory agencies publish formal recommendations. One of these refers to the time the PIC remains at the same site (residence time), which has been determined to be 96 hours for the adult population, i.e., it should be removed and punctured again at another site, systematically, even if not showing any inflammatory sign within 96 hours.
Following literature review, one can see that these recommendations are based on limited evidence, and supported by data from old studies. For this reason, the investigators discuss if employing a systematic and elective change procedure for adults would be the best option, as the investigators have taken some aspects into consideration, such as: Patient safety - The PIC dwell time at the placement site, as shown by research results, has increased throughout the decades to 24, 48, 72, and 96 hours. If the PIC change is performed on a child who, theoretically, is a less immune-competent patient as compared to adults, this is performed according to clinical signs, then the investigators can conclude that adopting the same procedure for adults would be safe. Peripheral venous depletion - Logic leads us to consider that the less the investigators puncture a patient, more access is available, and less outcomes with IT-specific complications occur. Patient satisfaction - With reduced exposures to painful and invasive events, the patient will also benefit from it. Few patients refrain from showing dissatisfaction when the PIC is to be placed again electively. Quality - Producing scientific evidence and adopting the best practices in hospital environments is practicing quality. Economic aspects - If these PIC changes were less frequent, they would necessarily imply less spending with inputs and devices, as well as less time spent by the team performing the procedure, which represents less cost and workload. Occupational safety - Studies show an estimated relationship between the occurrence of an accident with biological material and performing invasive procedures. Reducing the number of punctures performed by a professional, in addition to decreasing the workload, may reduce the exposure to risk and accidents.
Research studies carried out mostly in Australia aim at showing that the systematic PIC removal and change do not bring benefits, when compared to change based on clinical manifestations. However, a systematic review study in 2010 did not find conclusive evidence, and suggested the development of other projects in several regions, of different natures and realities, so as to further mature the hypothesis. To support this, the INS has also formally stated that this theme is a research priority at this time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| according to clinical signs | Experimental | Other: clinical signsremoval the peripheral catheter according to clinical signs |
| sistematically every 96 hours | No intervention | –removal the peripheral catheter every 96 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- any medical diagnosis, except for those stated as exclusion criteria, and
- with a therapeutic proposal of undergoing the therapy for at least 96 hours, or four days;
- agree with the proposals expressed in the Informed Consent Form (ICF); and
- have a catheter that has not been placed at the ER.
Key exclusion criteria (3 listed)
- medical diagnosis of immunosuppression or receiving immunosuppressants;
- using more than one peripheral catheter simultaneously;
- refusing to take part in the research.
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 |
|---|---|---|
| clinical signsto remove the peripheral venous catheter according clinical signs | Other | according to clinical signs |
Primary outcome
presence of phlebitis
Time frame: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
phlebitis (phlebitis/1000 peripheral venous catheters-day), stratified by severity.
5 secondary outcomes
presence of other complications related peripheral intravenous (PIC) therapy in the two groups
Time frame: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
time interval for peripheral intravenous catheter (PIC) changes
Time frame: For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days
total number of peripheral intravenous catheter (PIC)
Time frame: After randomization, from the first venous puncture, catheter fixation, until the removal of it, during the hospitalization. Average six days
Cost
Time frame: during the hospitalization, in average 5 to 6 days
The experience of the patient
Time frame: the questionnaire will be applied at the time of hospital discharge, hospitalization with average 6 days
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 Mar 2018.
- Derived from this study: PubMed 32334176Vendramim P, Avelar AFM, Rickard CM, Pedreira MDLG. The RESPECT trial-Replacement of peripheral intravenous catheters according to clinical reasons or every 96 hours: A randomized, controlled, non-inferiority trial. Int J Nurs Stud. 2020 Jul;107:103504. doi: 10.1016/j.ijnurstu.2019.103504. Epub 2020 Jan 11.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical signs in people with Phlebitis, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 3 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
presence of phlebitis (time frame: from catheter fixation, during the indwell time of the catheter, until the removal of it. For the control group, it will be up to 96 hours. From the interventional group, there is no time predict, average five or six days). 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 NCT02568670, which also lists 1 linked publication.
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 Mar 2018.