Clinical trial NCT04046770: Innovative Device for Intravenous Administration
Official title: Innovative Device for Intravenous Administration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Safety Issues
Medical Device
Keywords: safety
Effectiveness
Double-chamber syringe
Clinical research
medical devices
nurses
hospital setting
Lead sponsor: Escola Superior de Enfermagem de Coimbra
Sponsor class: OTHER
Collaborators: name: Hospital de Braga
name: Centro Hospitalar e Universitário de Coimbra, E.P.E.
name: Hospital Distrital da Figueira da Foz, EPE
First posted: 2019-08-06
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Catheter-related complications: phlebitis
timeFrame: 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.
measure: Catheter-related complications: infiltration
timeFrame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
measure: Catheter-related complications: occlusion
timeFrame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Secondary outcomes:
measure: Other catheter-related removal causes not related with the primary outcomes
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Coordinating Professor
name: Pedro Parreira, PhD
role: PRINCIPAL_INVESTIGATOR
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