Innovative Device for Intravenous Administration

Not Applicable

• Conditions: Safety Issues; Medical Device
• Interventions: Device: Drug administration and Flushing procedure using Double-Chamber Syringe; Device: Drug administration and Flushing procedure using Classic Syringe

• Registration Number: NCT04046770
• Lead Sponsor: Escola Superior de Enfermagem de Coimbra

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-03
• Study First Posted: 2019-08-06
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28
• Study Start: 2020-07
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-Chamber Syringe	Drug administration and Flushing procedure using Double-Chamber Syringe	Intravenous administration of drugs and flushing with the Double-Chamber Syringe
Classical Syringes	Drug administration and Flushing procedure using Classic Syringe	Intravenous administration of drugs and flushing with the classical syringe

Primary Outcome Measures

Name	Time	Method
Catheter-related complications: infiltration	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.
Catheter-related complications: occlusion	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
Catheter-related complications: phlebitis	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

Secondary Outcome Measures

Name	Time	Method
Other catheter-related removal causes not related with the primary outcomes	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.