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

Not Applicable

Completed

• Conditions: Catheterization, Peripheral
• Interventions: Device: PIVC pack

• Registration Number: NCT04085042
• Lead Sponsor: Escola Superior de Enfermagem de Coimbra

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2021-05-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-11-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIVC pack	PIVC pack	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).

Primary Outcome Measures

Name	Time	Method
PIVC-related complications	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.)

Secondary Outcome Measures

Name	Time	Method
Number of attempts to successful intravenous catheter placement	Immediately following intervention, an average of 5 minutes. This outcome will be assessed through study completion, an average of 6 months.
Nurse satisfaction	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	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.
Successful intravenous catheterization on the first attempt	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 attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.
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 satisfaction	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	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.

Trial Locations

Locations (1)

Instituto Português de Oncologia de Coimbra; 🇵🇹 Coimbra, Portugal