MedTrace Logo

Innovative Device for Intravenous Administration

NCT04046770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2019-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Safety Issues
  • Medical Device

Interventions

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.

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.

Sponsors & Collaborators

  • Hospital de Braga

    collaborator OTHER

  • Unidade Local de Saúde de Coimbra, EPE

    collaborator OTHER

  • Hospital Distrital da Figueira da Foz, EPE

    collaborator UNKNOWN

  • Escola Superior de Enfermagem de Coimbra

    lead OTHER

Principal Investigators

  • Pedro Parreira, PhD · Coordinating Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2020-10-31
Completion
2020-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046770 on ClinicalTrials.gov