Innovative Device for Intravenous Administration
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 主要终点
- Catheter-related complications: phlebitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients and clinical staff will not be entirely blind after group allocation due to the nature of the interventions. Despite this, participants will not be directly informed of their group allocation in terms of usual care or intervention, and the nurses in the clinical staff will only be informed about the broad purposes of the research [41] - the study of a new double-chamber syringe for intravenous administration and flushing. In contrast, research nurses from the team outside the orthopaedic department will be blinded when rating some of the main outcomes such as phlebitis and infiltration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
Double-Chamber Syringe
Intravenous administration of drugs and flushing with the Double-Chamber Syringe
干预措施: Drug administration and Flushing procedure using Double-Chamber Syringe (Device)
Classical Syringes
Intravenous administration of drugs and flushing with the classical syringe
干预措施: Drug administration and Flushing procedure using Classic Syringe (Device)
结局指标
主要结局
Catheter-related complications: phlebitis
时间窗: 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
Catheter-related complications: infiltration
时间窗: 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
时间窗: 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
次要结局
- 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.)
研究者
Pedro Miguel Santos Dinis Parreira
Ph.D, Coordinating Professor
Escola Superior de Enfermagem de Coimbra