Innovative Device for Intravenous Administration

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Medical Device
Safety Issues

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: None (Open Label)Masking Description: Patients and clinical staff will not be entirely blind after group allocation due to the nature of the interventions. Despite this, participants will not be directly informed of their group allocation in terms of usual care or intervention, and the nurses in the clinical staff will only be informed about the broad purposes of the research [41] - the study of a new double-chamber syringe for intravenous administration and flushing. In contrast, research nurses from the team outside the orthopaedic department will be blinded when rating some of the main outcomes such as phlebitis and infiltration.Primary Purpose: Other

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #

NCT04046770

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