Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial

Pedro Parreira, Liliana B Sousa, Inês A Marques, Paulo Santos-Costa, Luciene M Braga, Arménio Cruz, Anabela Salgueiro-Oliveira, Pedro Parreira, Liliana B Sousa, Inês A Marques, Paulo Santos-Costa, Luciene M Braga, Arménio Cruz, Anabela Salgueiro-Oliveira

Abstract

Background: The prevention of catheter-related complications is nowadays an important topic of research. Flushing 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 should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter).

Methods/design: 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 drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day.

Discussion: The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses' adoption of good clinical practices in intravenous procedures, reducing catheter manipulations.

Trial registration: ClinicalTrials.gov, NCT04046770. Registered 13 August 2019.

Keywords: Clinical research; Double-chamber syringe; Effectiveness; Safety.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of the parallel randomised controlled trial with two groups (CONSORT 2010)

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