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临床试验/NCT04472273
NCT04472273Unknown不适用

Comparison of the Efficiency of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application in Pediatric Patients With Sedation for Gastrointestinal System Endoscopy

Kocaeli Derince Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2020年2月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
82
试验地点
1
主要终点
Comparison of the effects of high-flow nasal cannula oxygen administration and nasal cannula oxygen administration on respiratory parameters in patients undergoing sedation in the pediatric endoscopy unit.

研究概览

简要总结

Recently, sedation practices have increased for diagnostic and interventional procedures for children in non-operating rooms. On the other hand, the rate of respiratory complications especially in non-operating room sedation applications is quite high. Oxygen therapy in sedation applied to non-operating room endoscopy patients is mostly performed with classical nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been increasing.

According to the classical nasal cannula oxygen therapy application where non-moistened oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L / min. This method has many advantages. Some of those; makes it possible to provide high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space. It provides discharge of expired air in the upper airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream adjusted to all children. Flow and titration can be adjusted according to the child's weight and effect. Physiological evidence in the pediatric population indicates that flows equal to or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve breathing and accelerate the emptying of the respiratory muscles. Because of all these features, high-flow nasal cannula oxygen therapy application is used safely in pediatric patients.

In general, it is reported that in non-operating room anesthesia, sedation or anesthesia applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have respiratory complications and bradycardia due to hypoxemia.

In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal cannula oxygen application, which is routinely used in sedation applications in the pediatric endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.

详细描述

Recently, sedation practices have increased for diagnostic and interventional procedures for children in non-operating rooms. On the other hand, the rate of respiratory complications especially in non-operating room sedation applications is quite high. Oxygen therapy in sedation applied to non-operating room endoscopy patients is mostly performed with classical nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been increasing.

Classical nasal cannula oxygen therapy application; It is a system made of plastic or rubber material with two open ends placed in the patient's nostrils. It is the most commonly used oxygen therapy application method. However, it has some disadvantages. The most important of these is that the oxygen given in this method cannot be humidified, causing drying in mucous membranes at high flow rates of more than 4 L / min and problems in patient compliance. This situation prevents us to increase the oxygen FiO2 rate applied to the patient above 40%.

According to the classical nasal cannula oxygen therapy application where non-moistened oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L / min. This method has many advantages. Some of those; makes it possible to provide high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space. It provides discharge of expired air in the upper airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream adjusted to all children. Flow and titration can be adjusted according to the child's weight and effect. Physiological evidence in the pediatric population indicates that flows equal to or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve breathing and accelerate the emptying of the respiratory muscles. Because of all these features, high-flow nasal cannula oxygen therapy application is used safely in pediatric patients.

In general, it is reported that in non-operating room anesthesia, sedation or anesthesia applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have respiratory complications and bradycardia due to hypoxemia.

In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal cannula oxygen application, which is routinely used in sedation applications in the pediatric endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Children aged 4-18 years
  • Patients undergoing gastroenterological intervention
  • Patients undergoing sedation
  • Patients with ASA 1-2 risk group
  • Patients who have been informed of the study for informed consent

排除标准

  • Patients under 4 years old and over 18 years old
  • Patients with ASA 3 and above risk groups
  • Patients who refuse to participate in the study

结局指标

主要结局

Comparison of the effects of high-flow nasal cannula oxygen administration and nasal cannula oxygen administration on respiratory parameters in patients undergoing sedation in the pediatric endoscopy unit.

时间窗: SpO2 values of patients at admission, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded. After the procedure, SpO2 and ETCO2 values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.

SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications.

次要结局

  • Comparison of the effects of high flow nasal cannula oxygen administration and nasal cannula oxygen administration on hemodynamic parameters in patients undergoing sedation in the pediatric endoscopy unit.(HR and blood pressure values of patients at admission, 1 minute, 5 minutes, 10 minutes 15 minutes and 20 minutes will be recorded. After the procedure, HR values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.)

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sami Olcay Özbay

MD, RESİDENT

Kocaeli Derince Education and Research Hospital

研究点 (1)

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