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

Sponsor
Escola Superior de Enfermagem de Coimbra (Other)
Overall Status
Completed
CT.gov ID
NCT04085042
Collaborator
Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E. (Other)
200
1
2
7
28.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PIVC pack
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual Care

Usual care during peripheral venous catheterization. Nurses will continue with the normal routine practice, by preparing all needed material individually.

Experimental: 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).

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.]

  3. 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.]

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Português de Oncologia de Coimbra Coimbra Portugal

Sponsors and Collaborators

  • Escola Superior de Enfermagem de Coimbra
  • Instituto Português Oncologia de Coimbra Francisco Gentil E. P. E.

Investigators

  • Principal Investigator: Paulo Costa, MSc, The Health Sciences Research Unit: Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Paulo Costa, MSc, RN, Escola Superior de Enfermagem de Coimbra
ClinicalTrials.gov Identifier:
NCT04085042
Other Study ID Numbers:
  • Esenfc
First Posted:
Sep 11, 2019
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paulo Costa, MSc, RN, Escola Superior de Enfermagem de Coimbra

Study Results

No Results Posted as of Mar 23, 2022