Innovative Device for Intravenous Administration

Study Overview
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Brief Summary
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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.

Official Title
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Innovative Device for Intravenous Administration

Conditions
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Safety Issues, Medical Device

Intervention / Treatment
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* Device: Drug administration and Flushing procedure using Double-Chamber Syringe
* Device: Drug administration and Flushing procedure using Classic Syringe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-Chamber Syringe<br>Intravenous administration of drugs and flushing with the Double-Chamber Syringe | Device: Drug administration and Flushing procedure using Double-Chamber Syringe<br>* 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.<br>|
| Active Comparator: Classical Syringes<br>Intravenous administration of drugs and flushing with the classical syringe | Device: Drug administration and Flushing procedure using Classic Syringe<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related complications: phlebitis | 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 | 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. | 
| Catheter-related complications: infiltration | 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. | This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months). | 
| Catheter-related complications: occlusion | 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 | This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other catheter-related removal causes not related with the primary outcomes | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, Effectiveness, Double-chamber syringe, Clinical research, medical devices, nurses, hospital setting