跳至主要内容
临床试验/NCT05189236
NCT05189236已完成不适用

The Effect of Cold Steam Application on Body Temperature in Fever Management in Children with Febrile Neutropenia

Acibadem University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Body temperature

研究概览

简要总结

The aim of this study is to determine the effect of the cold steam application on body temperature in combination with the treatment algorithm in fever management in children with febrile neutropenia.

详细描述

Fever and neutropenia are common side effects of the myelosuppressive chemotherapy paediatric oncology patients undergo. This is one of the most prevalent causes of non-elective hospitalizations in patients in the population, accounting for 19% of patient applications. The fever that develops with neutropenia can result in significant complications, including brain damage, seizures and death. Therefore, it is critical to follow up patients at risk for signs and symptoms of infection, such as fever, chills or sweating, and to ensure effective fever management.

This research was designed to be conducted as a randomised controlled experiment study until the entire sample group identified in the Paediatric Oncology Service was reached. The algorithm of neutropenia management is used to treat children who are followed up at the paediatric oncology service, where the study will be conducted, due to febrile neutropenia. The control group will consist of children who have been treated using this algorithm (only the algorithm); whereas, the experimental group will consist of the children who will be applied to cold stream in addition to this algorithm (the algorithm + cold steam application). The body temperature values of patients in the experimental and control groups will be compared (from baseline to discharge (average 3 days)).

Cold Steam Application A nebulizer is positioned in the room, and the hose end, through which the steam is released, is supplied to the ambient air and operated in continuous mode during the cold steam application.

An Atom Sanilizer 30 ultrasonic nebulizer will be used to supply cold steam to every patient. The steam capacity of the device is 2.5 ml./min., the output power is 30 W.

The nebulizer will be used solely in the patient's room from the time the patient is admitted until his temperature is stabilised. During the private use period, the machine will not be exchanged between patients. During patient use, the device is cleaned with alcohol-based rapid surface disinfectant once a day. If another patient needs it, another device in the clinic will be utilized. The unit and the hospital already have a sufficient number of devices. After the patients' usage of the nebulizer is ended, the appliance is cleaned by using an alcohol-based rapid surface disinfectant, and the accessories are sterilized with a medium-level disinfectant in the Central Sterilization Unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The children and/or children's parents have agreed to participate in the study and have signed the informed consent form and
  • •Who are from the age of one month to eighteen years old,
  • •Children treated for febrile neutropenia
  • •Have a stable clinical condition will be included in the study

排除标准

  • •The children who have received a treatment protocol other than the algorithm of neutropenia management will be excluded from the study.

研究组 & 干预措施

Control Group (Only Algorithm of Febrile Neutropenia Management)

Other

The algorithm of febril neutropenia management is used to treat children who are followed up at the paediatric oncology service, where the study will be conducted, due to febrile neutropenia. The control group will consist of children who have been treated using this algorithm (only the Algorithm of Febrile Neutropenia Management).

干预措施: Control Group (Only Algorithm of Febrile Neutropenia Management) (Procedure)

Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)

Experimental

The experimental group will consist of the children who will be applied to cold steam in addition to this algorithm (Algorithm of Febrile Neutropenia Management + cold steam application).

干预措施: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam) (Procedure)

结局指标

主要结局

Body temperature

时间窗: From baseline to discharge (average 3 days)

The body temperature values of patients in the experimental and control groups will be compared (from baseline to discharge (average 3 days). Body temperature measurement will be evaluated as axillary.

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Kan Onturk

Assist. Prof.

Acibadem University

研究点 (1)

Loading locations...

相似试验