Catheterization, PeripheralMultiCatNCT04085042
Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
A study testing PIVC pack in people with Catheterization, Peripheral, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- PIVC pack
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2021to 30 Nov 2021
- 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
- Participants who require peripheral intravenous catheterization as part of their therapeutic plan (caliber 20G or 22G);
- Participants whose primary nurse agrees to participate in the study;
- Participants who are able to give written assent or oral assent.
Who cannot join
- Confused and/or disoriented participants;
- Participants who are unable to communicate orally and/or in writing.
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. The traditional approach to PIVC is considered reactive and ineffective, resulting in the exhaustion of the patients' peripheral venous access prior to consideration of other access methods and options (Moureau et al., 2012).
Evidence suggests that the safety and effectiveness of patients with a peripheral catheter are also intrinsically associated with the adequacy of materials and technologies used in clinical contexts for vein selection, as well as for catheter insertion and maintenance care (Marsh, Webster, Mihala \& Rickard, 2017). Several studies point to the inadequacy of the technologies and medical devices used in this area, enhancing the occurrence of complications such as infection, phlebitis, occlusion and accidental catheter removal (Braga, 2017; Costa, 2017; Nobre \& Martins, 2018).
The project investigators aim to determine whether the use of a PIVC pack will significantly reduce associated complications when compared with the usual care. Additionally, the research team aims to determine if the use of a PIVC pack will reduce the number of insertion attempts and overall procedure time, as well as improving patient and provider satisfaction.
- Conditions
- Catheterization, Peripheral
- Being tested
- PIVC pack
- Keywords
- Catheterization, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIVC packDevice
The PIVC pack is a sterile container that includes inside all the need devices to perform peripheral catheterization. The pack is color-coded to inform healthcare professionals about the catheter caliber inside.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually. |
| PIVC pack | Experimental | Nurses will use a sterile pack that includes all needed devices for peripheral intravenous catheterization according to the latest evidence (eg, cannula, swabs, disposable tourniquet, antiseptic). Receives: Device: PIVC pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIVC-related complications
Evaluated through a self-report scale where the nurse identifies a set of indicators associated to the occurrence of immediate complications during the procedure (extravasation, puncture of proximal anatomical structures, hematoma, etc.)
Measured: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Secondary outcomes (5)
Successful intravenous catheterization on the first attempt
Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.
Measured: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Number of attempts to successful intravenous catheter placement
Measured: Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Time to successful placement (in minutes)
Measured: From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Patient satisfaction
Evaluated through a self-report scale where the participant identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.
Measured: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months
Nurse satisfaction
Evaluated through a self-report scale where the nurse identifies a set of indicators associated to their satisfaction with the intervention, when compared to previous experiences.
Measured: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 May 2021
- Primary completion30 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Catheterization, PeripheralStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.
- Responsible party
- Principal investigator, Paulo Costa, Escola Superior de Enfermagem de Coimbra
- Investigators
- Paulo Costa, MSc, Principal investigator, The Health Sciences Research Unit: Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085042
- Sponsor's protocol ID
- Esenfc
- Acronym
- MultiCat
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Moureau NL, Trick N, Nifong T, Perry C, Kelley C, Carrico R, Leavitt M, Gordon SM, Wallace J, Harvill M, Biggar C, Doll M, Papke L, Benton L, Phelan DA. Vessel health and preservation (Part 1): a new evidence-based approach to vascular access selection and management. J Vasc Access. 2012 Jul-Sep;13(3):351-6. doi: 10.5301/jva.5000042.
PubMed 22307471Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters: A Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:12-19. doi: 10.1016/j.ijnurstu.2016.11.007. Epub 2016 Nov 16.
PubMed 27889585Nobre A., Martins M. Prevalência de flebite da venopunção periférica: fatores associados. Revista de Enfermagem Referência 4(16): 127-138, 2018.
Braga L. Práticas de enfermagem e a segurança do doente no processo de punção de vasos e na administração da terapêutica endovenosa (Doctoral Thesis). Universidade de Lisboa, 2017.
Costa P. Gestão de Material Clínico de Bolso por Enfermeiros: fatores determinantes e diversidade microbiológica (Masters' Dissertation). Escola Superior de Enfermagem de Coimbra, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
- ClinicalTrials.gov ID
- NCT04085042
- Acronym / sponsor ID
- MultiCat / Esenfc
- Conditions
- Catheterization, Peripheral
- Keywords
- Catheterization, Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 11 Sep 2019 (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.
Peripheral intravenous catheterization (PIVC) is the most frequent invasive clinical procedure in a hospital setting, associated with significant complication rates for the patient, compromising their well-being, as well as the quality, safety, and efficacy of the care provided. The traditional approach to PIVC is considered reactive and ineffective, resulting in the exhaustion of the patients' peripheral venous access prior to consideration of other access methods and options (Moureau et al., 2012).
Evidence suggests that the safety and effectiveness of patients with a peripheral catheter are also intrinsically associated with the adequacy of materials and technologies used in clinical contexts for vein selection, as well as for catheter insertion and maintenance care (Marsh, Webster, Mihala \& Rickard, 2017). Several studies point to the inadequacy of the technologies and medical devices used in this area, enhancing the occurrence of complications such as infection, phlebitis, occlusion and accidental catheter removal (Braga, 2017; Costa, 2017; Nobre \& Martins, 2018).
The project investigators aim to determine whether the use of a PIVC pack will significantly reduce associated complications when compared with the usual care. Additionally, the research team aims to determine if the use of a PIVC pack will reduce the number of insertion attempts and overall procedure time, as well as improving patient and provider satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually. |
| PIVC pack | Experimental | Device: PIVC packNurses will use a sterile pack that includes all needed devices for peripheral intravenous catheterization according to the latest evidence (eg, cannula, swabs, disposable tourniquet, antiseptic). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who require peripheral intravenous catheterization as part of their therapeutic plan (caliber 20G or 22G);
- Participants whose primary nurse agrees to participate in the study;
- Participants who are able to give written assent or oral assent.
Key exclusion criteria (2 listed)
- Confused and/or disoriented participants;
- Participants who are unable to communicate orally and/or in writing.
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 |
|---|---|---|
| PIVC packThe PIVC pack is a sterile container that includes inside all the need devices to perform peripheral catheterization. The pack is color-coded to inform healthcare professionals about the catheter caliber inside. | Device | PIVC pack |
Primary outcome
PIVC-related complications
Time frame: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Evaluated through a self-report scale where the nurse identifies a set of indicators associated to the occurrence of immediate complications during the procedure (extravasation, puncture of proximal anatomical structures, hematoma, etc.)
5 secondary outcomes
Successful intravenous catheterization on the first attempt
Time frame: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months
Number of attempts to successful intravenous catheter placement
Time frame: Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Time to successful placement (in minutes)
Time frame: From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Patient satisfaction
Time frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months
Nurse satisfaction
Time frame: This outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 months
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 23 Mar 2022.
- Background: PubMed 22307471Moureau NL, Trick N, Nifong T, Perry C, Kelley C, Carrico R, Leavitt M, Gordon SM, Wallace J, Harvill M, Biggar C, Doll M, Papke L, Benton L, Phelan DA. Vessel health and preservation (Part 1): a new evidence-based approach to vascular access selection and management. J Vasc Access. 2012 Jul-Sep;13(3):351-6. doi: 10.5301/jva.5000042.
- Background: PubMed 27889585Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters: A Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:12-19. doi: 10.1016/j.ijnurstu.2016.11.007. Epub 2016 Nov 16.
- BackgroundNobre A., Martins M. Prevalência de flebite da venopunção periférica: fatores associados. Revista de Enfermagem Referência 4(16): 127-138, 2018.
- BackgroundBraga L. Práticas de enfermagem e a segurança do doente no processo de punção de vasos e na administração da terapêutica endovenosa (Doctoral Thesis). Universidade de Lisboa, 2017.
- BackgroundCosta P. Gestão de Material Clínico de Bolso por Enfermeiros: fatores determinantes e diversidade microbiológica (Masters' Dissertation). Escola Superior de Enfermagem de Coimbra, 2017.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Paulo Costa, MSc principal investigator
The Health Sciences Research Unit: Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIVC pack in people with Catheterization, Peripheral, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
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 3 inclusion and 2 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 23 Mar 2022. 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 Portugal. 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?
PIVC-related complications (time frame: This outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months). 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 NCT04085042, which also lists 5 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 23 Mar 2022.