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临床试验/NCT07234175
NCT07234175招募中不适用

Comparison of a Procedural Oxygen Mask and Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Prospective Randomized Controlled Trial

Bedirhan Günel1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
114
试验地点
1
主要终点
Lowest SpO₂ level during procedure

研究概览

简要总结

Upper gastrointestinal endoscopy is a commonly performed diagnostic and, when necessary, therapeutic procedure in pediatric patients for the evaluation of the esophagus, stomach, and duodenum. Additional interventions such as biopsy, foreign body removal, or polypectomy can also be performed during the same session. Sedation is generally required during the procedure, and the depth of sedation is often greater than that used for routine examinations.

Because of anatomical and physiological differences in children-such as smaller airway diameter, higher oxygen consumption, and lower functional residual capacity-the risks of upper airway obstruction, hypoxemia, and hypoventilation are higher than in adults. The passage of the endoscope through the mouth, combined with the respiratory depressant effects of sedatives and the smaller airway diameter, increases the likelihood of hypoxemia and limits the anesthesia team's access to the airway. Therefore, maintaining airway stability and optimizing oxygenation during sedation are particularly critical in pediatric patients.

Currently, several oxygen delivery methods are used during upper gastrointestinal endoscopy, including conventional nasal cannulas, high-flow nasal oxygen systems, and procedural oxygen masks. The Procedural Oxygen Mask (POM™) is a specially designed device that delivers oxygen through both the mouth and nose while allowing endoscope passage and continuous capnography monitoring. Previous studies in adults have shown that the use of POM™ or high-flow nasal oxygen reduces the incidence of hypoxemia during endoscopy. However, in children, there is a lack of randomized controlled trials directly comparing POM™ with nasal cannula use.

This single-center prospective randomized controlled trial aims to compare the effectiveness of the Procedural Oxygen Mask (POM™) and nasal cannula in preventing hypoxemia during pediatric upper gastrointestinal endoscopy under sedation. The findings are expected to contribute to safer sedation practices and improved airway management strategies in pediatric endoscopic procedures.

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
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who consented to participate in the study
  • •Aged between 6 and 16 years
  • •Body weight >30 kg
  • •ASA physical status I-II
  • •Children scheduled to undergo procedural sedation for non-emergency upper gastrointestinal endoscopy

排除标准

  • •Lack of parental consent or refusal to sign the participant consent form
  • •History of endotracheal intubation within the past 3 months
  • •History of lower respiratory tract infection within the past 3 months
  • •History of intensive care unit (ICU) admission within the past 3 months
  • •Presence of a tracheostomy
  • •History of tracheostomy placement
  • •Patients with oxygen dependency due to any underlying disease
  • •Known pulmonary or cardiac disease
  • •Known congenital craniofacial anomalies
  • •Congenital or acquired upper airway malformations

研究组 & 干预措施

Group P

Experimental

Participants will receive oxygen via a Procedural Oxygen Mask (POM) at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation.

干预措施: Procedural Oxygen Mask (Device)

Group N

Active Comparator

Participants will receive oxygen via a conventional nasal cannula at a flow rate of 5 L/min during upper gastrointestinal endoscopy under sedation.

干预措施: Nasal Cannula (Device)

结局指标

主要结局

Lowest SpO₂ level during procedure

时间窗: From the start of sedation to end of endoscopy (typically 5-20 minutes)

The lowest peripheral oxygen saturation (SpO₂) recorded between the initiation of sedation and the removal of the gastroscope was defined as the primary outcome. It was measured via continuous pulse oximetry, and when SpO₂ fluctuated, the value maintained for more than 10 seconds was recorded.

次要结局

  • Incidence of hypoxemia(During endoscopic procedure (from sedation start to endoscope removal))
  • Number of hypoxemic episodes(During endoscopic procedure)
  • Duration of hypoxemia (in seconds)(During endoscopic procedure)
  • Airway interventions(During endoscopic procedure)
  • Hemodynamic complications(During endoscopic procedure)
  • Gastroenterologist satisfaction score(During endoscopic procedure)

研究者

发起方
Bedirhan Günel
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Bedirhan Günel

Principal Investigator

Kocaeli City Hospital

研究点 (1)

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