Innovative Device for Intravenous Administration (SeringaDUO)

Escola Superior de Enfermagem de Coimbra

Status: Unknown

Conditions: Medical Device; Safety Issues

Treatments: Device: Drug administration and Flushing procedure using Double-Chamber Syringe; Device: Drug administration and Flushing procedure using Classic Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT04046770

SeringaDuo

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

146 participants in 2 patient groups

Double-Chamber Syringe

Experimental group

Description:

Intravenous administration of drugs and flushing with the Double-Chamber Syringe

Treatment:

Device: Drug administration and Flushing procedure using Double-Chamber Syringe

Classical Syringes

Active Comparator group

Description:

Intravenous administration of drugs and flushing with the classical syringe

Treatment:

Device: Drug administration and Flushing procedure using Classic Syringe