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Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients

Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04085042
Acronym
MultiCat
Enrollment
200
Registered
2019-09-11
Start date
2021-05-01
Completion date
2021-11-30
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheterization, Peripheral

Keywords

Catheterization, Peripheral

Brief 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. 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.

Interventions

DEVICEPIVC pack

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.

Sponsors

Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.
CollaboratorUNKNOWN
Escola Superior de Enfermagem de Coimbra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Confused and/or disoriented participants; * Participants who are unable to communicate orally and/or in writing.

Design outcomes

Primary

MeasureTime frameDescription
PIVC-related complicationsThis outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 monthsEvaluated 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.)

Secondary

MeasureTime frameDescription
Successful intravenous catheterization on the first attemptThis outcome will be assessed immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 monthsSuccessful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.
Number of attempts to successful intravenous catheter placementImmediately 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)From time of randomization until the time of successful intravenous catheter placement, assessed through study completion, an average of 6 months.
Patient satisfactionThis outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 monthsEvaluated 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.
Nurse satisfactionThis outcome will be assessed immediately following intervention, an average of 20 minutes. This outcome will be assessed through study completion, an average of 6 monthsEvaluated 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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026