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OpenTrials
Completed

NCT Number: NCT04085042

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

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.

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Key information

Conditions

Catheterization, Peripheral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Português de Oncologia de Coimbra

Coimbra, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIVC pack

Device

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.

Primary outcomes

  1. 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.)

Secondary outcomes

  1. 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

    Successful attempt is defined through the clear flush of the catheter with 5 mL of normal saline without extravasation.

  2. 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.

  3. 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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Escola Superior de Enfermagem de Coimbra

Other

Collaborators

  • Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.

Registry information

Acronym: MultiCat

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2019
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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