INVESTIGATION OF THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT. A RANDOMIZED OPEN-LABEL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- the rate of development of phlebitis
研究概览
简要总结
This study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving IV amiodarone infusion treatment.
Study Hypotheses H0-1: There is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.
H0-2: There is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.
H0-3: There is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% Dextrose in 30 minutes (24 hour-infusion),
- •Patients to whom PVC was placed in the upper extremity, and who did not develop phlebitis on the PVC site
排除标准
- •Cold allergy/sensitivity or circulatory disorders
- •During the study, patients who had a change in the IV amiodarone treatment protocol, whose IV amiodarone treatment was terminated before 24 hours, whose IV amiodarone treatment protocol was started, but PVC had to be replaced for any reason during the 24-hour period
结局指标
主要结局
the rate of development of phlebitis
时间窗: 24+2 hours
the patients were observed for the development of phlebitis for 24 hours until the end of the procedure and for 2 hours after the end of the treatment.During the treatment, the development of phlebitis after cold application during the 24-hour infusion was evaluated every 2 hours by the researcher using the "Visual Infusion Phlebitis Scale" and recorded.
次要结局
- the grade of phlebitis(24+2 hours)
研究者
Tulay Basak
Principal Investigator
Saglik Bilimleri Universitesi