An interventional study of PIVC pack in Catheterization, Peripheral, sponsored by Escola Superior de Enfermagem de Coimbra. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Escola Superior de Enfermagem de Coimbra · Not applicable, Interventional, and Prevention
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.
Escola Superior de Enfermagem de Coimbra is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually.
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).
Device: PIVC 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.
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.)
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
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.
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
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.
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
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.
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
Plan to share: No — IPD will not be shared with other researchers.
Ran from May 2021 to primary completion in Oct 2021, 5 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Escola Superior de Enfermagem de Coimbra