The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- demographic data
研究概览
简要总结
It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to these events. In addition, it is aimed to evaluate the relationship between these parameters by using devices measuring skin moisture, skin pH and Neonatal Skin Condition Assessment Scale in experimental and control groups.
详细描述
The aim of this study is to investigate the effectiveness of surgical incision drape usage for securing endotracheal tubes in preterm neonates. The study will be conducted using a randomized controlled design, and participants will be divided into two groups: those using the surgical drape and those not using it. The population of the study will consist of preterm infants who are hospitalised in the neonatal intensive care unit of Batman Training and Research Hospital. Intubated preterm infants between 28-34 weeks will be included in the study regardless of gender difference. Research data will be collected by the following methods: Demographic information, Neonatal Skin Condition Rating Scale (NSCS), Skin Ph meter device and skin moisture meter device. Data will be collected every 24 hours during the intubation period. The results of the study are expected to provide important theoretical and practical contributions. The effects of parameters such as skin wounds that may occur due to endotracheal tube fixation in infants, unplanned extubation rates, skin pH and skin moisture at the site of intubation fixation will be compared between the surgical incision drep and the standard group. The research data will be analysed using IBM SPSS 27.0 Programme (Statistical Package for Social Sciences).
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
- None
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit,
- •Intubated infants on invasive mechanical ventilators,
- •Babies who were orally intubated were included in the study.
排除标准
- •Congenital skin condition,
- •With circulatory problems,
- •Congenital anomalies and metabolic disorders,
- •Small for gestational age (SGA) and large for gestational age (LGA),
- •Unplanned extubation taking place,
- •Babies intubated for less than 24 hours will be excluded from the study.
研究组 & 干预措施
Surgical Incision Drape
Participants in this group will have their endotracheal tube (ETT) secured using a surgical incision drape. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of silk plasters.
干预措施: surgical incision drep (Other)
silk plasters
The endotracheal tube (ETT) of the participants in this group will be secured using silk plasters. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of a surgical incision drape.
干预措施: surgical incision drep (Other)
结局指标
主要结局
demographic data
时间窗: through study completion, an average of 1 year
It will consist of questions such as gestational week, birth weight, postnatal age, frequency of endotracheal tube re-fixation, reason for hospitalization, frequency of aspiration, mode of delivery, gender, phototherapy status, antibiotic status, sedative use, analgesic use, ventilator mode.
次要结局
- skin ph meter and skin moisture meter(through study completion, an average of 1 year)
研究者
Barış Çelik
Phd student
Hasan Kalyoncu University