Innovative Device for Intravenous Administration (SeringaDUO)

August 27, 2019 updated by: Pedro Miguel Santos Dinis Parreira, Escola Superior de Enfermagem de Coimbra

The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter).

A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pedro Parreira, PhD
  • Phone Number: 3302 +351 239802850 / 239487200
  • Email: parreira@esenfc.pt

Study Contact Backup

  • Name: Anabela Salgueiro-Oliveira, PhD
  • Phone Number: 3302 +351 239802850 / 239487200
  • Email: anabela@esenfc.pt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with 18 years or above, admitted to the orthopaedic department;
  • Patients with the ability to fully communicate in Portuguese;
  • Patients able to consent;
  • Prescribed PIVC for intravenous therapeutic administration;
  • PIVC expected to remain for at least 24 hours;
  • PIVC inserted at the orthopaedic department;
  • PIVC size 18 gauge (G) or 20 G;
  • Anatomical insertion site in arm, forearm, or back of the hand;
  • PIVC secured with a transparent, semi-permeable polyurethane film dressing.

Exclusion Criteria:

  • - Patients with a known infectious disease;
  • Patients with leucocytosis, defined as ≥1200 leukocytes/mm3;
  • Patients with anaemia, with haemoglobin levels <13g/dl for men, and <12g/dl for women;
  • Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;
  • Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;
  • Patients with body mass index below 16 kg/m2 or above 39 kg/m2;
  • Anatomical insertion site in flexion areas (e.g. cubital fossa region) or lower members;
  • Skin lesions at the insertion site (e.g. previous infiltration, dermatitis, burns) and skin alterations such as tattoos;
  • Peripheral venous alterations resulting from previous hospital admissions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-Chamber Syringe
Intravenous administration of drugs and flushing with the Double-Chamber Syringe
Device: Drug administration and Flushing procedure using Double-Chamber Syringe
The new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device.
Active Comparator: Classical Syringes
Intravenous administration of drugs and flushing with the classical syringe
Device: Drug administration and Flushing procedure using Classic Syringe
To fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter-related complications: phlebitis
Time Frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.
Phlebitis (the irritation or inflammation to the vein wall, associated with warmth, tenderness, erythema or palpable cord) is the most frequent PIVC-related complication, which may have mechanical, chemical, or bacterial causes
This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.
Catheter-related complications: infiltration
Time Frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Moreover, the extravasation or infiltration of fluids may be responsible for local oedema due to the pervasion of intravenous fluid into the interstitial compartment, causing inflammation of the tissue around the catheter site.
This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Catheter-related complications: occlusion
Time Frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Occlusion is defined as any circumstance in which the Peripheral Intravenous Catheter (PIVC) does not enable to flush the catheter or infuse fluids/medications and it is a clinical sign of catheter malfunctioning
This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other catheter-related removal causes not related with the primary outcomes
Time Frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.
The secondary outcomes involve other reasons for catheter removal (e.g. accidental dislodgment), maintenance time of the catheter, number of syringes and catheters used during the intravenous treatment, catheterization attempts, nurses' perception about risk and safety, as well as the satisfaction of the participant.
This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Enfermagem de Coimbra

Collaborators

Hospital de Braga
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Hospital Distrital da Figueira da Foz, EPE

Investigators

  • Principal Investigator: Pedro Parreira, PhD, Coordinating Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 3, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SeringaDuo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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