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临床试验/NCT04458441
NCT04458441Unknown不适用

Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?

Zekai Tahir Burak Women's Health Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
change feeling of pain and restlessness in premature

研究概览

简要总结

Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.

详细描述

Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral central catheter will be included in the study. In the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. The investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. The investigators predicted that the premature baby would have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take both video recordings during the application and N-PASS evaluation by an experienced person who does not know the povidone iodine temperature used .In preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were administered by a single experienced person. The study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the N-PASS assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • below 32 gestational weeks and / or 1250 grams preterm babies neonates requiring total parenteral nutrition, antibiotic therapy for at least 7 days, -

排除标准

  • major congenital anomalilies refusal to sign consent patient with previously attemped or placed central lines

结局指标

主要结局

change feeling of pain and restlessness in premature

时间窗: every 10 seconds before the 5 minutes and during the procedure

Evaluation of pain score in the patient during the procedure with n-pass evaluation

次要结局

  • protection of body temperature(before 5 min, during procedure)

研究者

发起方
Zekai Tahir Burak Women's Health Research and Education Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Funda Yavanoglu Atay

principal investigator

Zekai Tahir Burak Women's Health Research and Education Hospital

研究点 (1)

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