A Randomised-controlled Trial on the Effectiveness of Topical Sesame Oil in Preventing Phlebitis at Intravenous Cannula Sites in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 2
- 主要终点
- Phlebitis incidence
研究概览
简要总结
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
The main question it aims to answer is:
Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital?
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Researchers will compare the phlebitis incidence and severity of each group to see if topical sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
详细描述
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
All newly admitted patients with an existing IV cannula will be approached after being admitted into an inpatient ward. This will take place within 12 hours of the IV cannula insertion. They will not be approached if in distress, drowsy or immediately prior to a surgical procedure. The IV cannula will be tested for patency, and assessed for redness, swelling, pain, a palpable venous cord or pyrexia. If any of these symptoms are present, or if the IV cannula is not patent, the recruitment will be terminated.
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Demographic and clinical data will be recorded into a table. The patient will be instructed not to wash or wipe the topical agent off. The time and date of the start of treatment applied and subsequent treatments at 12 hour intervals will be documented. At the start of the study and at each 12 hour interval, the investigator will observe for signs of phlebitis using the modified Visual Infusion Phlebitis (VIP) scoring tool (1), before application of the next treatment. The study investigators will be the only ones applying the treatment/control and completing the data collection form every 12 hours.
Application of the treatment or control will be made every 12 hours for up to 72 hours, where the IV cannula will then be removed according to hospital guidelines. The IV cannula site will be observed, every 12 hours for up to 24 hours post IV cannula removal, for phlebitis or complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-80
- •Patients must speak and understand either English or Mandarin
- •Patients who possess a peripheral IV cannula
- •IV cannula must have been inserted for less than 12 hours
- •IV cannula must be on an upper extremity
- •IV cannula must be patent
- •IV cannula sites must show no signs of redness, swelling, pain, a palpable venous cord or pyrexia
- •Patient must be admitted to a cardiology ward in the National Heart Centre Singapore
排除标准
- •Patients who do not speak or understand either English or Mandarin
- •Patients with venous insufficiency
- •Patients with coagulopathies
- •Patients with cognitive or sensory impairments that would inhibit their ability to rate their pain via a Numerical Rating Scale (NRS)
- •Patients who are receiving medications that might interfere with timely reporting of adverse events (eg. medications that cause severe drowsiness)
- •Patients who report allergies to sesame or liquid paraffin oil
- •IV cannulas that were inserted and used for resuscitation
- •Patients with existing skin conditions that cause their skin to be red or swollen and might affect the investigators ability to assess for phlebitis
- •Patients who possess more than one peripheral IV cannula will only be included in the study once. All subsequent IV cannula insertions will be excluded.
结局指标
主要结局
Phlebitis incidence
时间窗: At 12 hourly intervals for a total of 72 hours
Measuring the incidence of phlebitis across both the intervention and control groups
次要结局
- Phlebitis severity(At 12 hourly intervals for a total of 72 hours)