Comparison of a Procedural Oxygen Mask and High-Flow Nasal Cannula for the Prevention of Hypoxemia During Pediatric Upper Gastrointestinal Endoscopy Under Sedation: A Single-Center Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 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 therapeutic procedure in children, allowing evaluation of the esophagus, stomach, and duodenum, as well as interventions such as biopsy, foreign body removal, and polypectomy. Sedation is routinely used, often at greater depths than for standard examinations. Due to anatomical and physiological differences, including smaller airway diameter, higher oxygen consumption, and lower functional residual capacity, pediatric patients are at higher risk of airway obstruction, hypoxemia, and hypoventilation compared to adults. The passage of the endoscope through the mouth further limits airway access and increases the risk of desaturation. Oxygenation during pediatric endoscopy is typically supported using nasal cannulas, high-flow systems, or procedural oxygen masks (POM™). This pilot randomized study aims to compare POM™ and high-flow nasal cannula in preventing hypoxemia during sedated pediatric upper gastrointestinal endoscopy, contributing evidence for safer sedation and airway management practices in children.
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
Oxygen delivered via Procedural Oxygen Mask (POM™) at a fixed flow of 15 L/min (approx. FiO₂ 95%) throughout the procedure.
干预措施: Procedural Oxygen Mask (Device)
Group H
Oxygen delivered via HFNC at 30 L/min, 35 °C, targeting FiO₂ 95% during the procedure.
干预措施: High-Flow 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))
- Duration of hypoxemia (in seconds)(During endoscopic procedure)
- Incidence of hypoxemia(During endoscopic procedure (from sedation start to endoscope removal))
- Duration of hypoxemia (in seconds)(During endoscopic procedure)
- Incidence of Device Repositioning(During endoscopic procedure)
- Number of hypoxemic episodes(During endoscopic procedure)
- Airway interventions(During endoscopic procedure)
- Hemodynamic complications(During endoscopic procedure)
- Gastroenterologist satisfaction score(During endoscopic procedure)
研究者
Bedirhan Günel
Principal Investigator
Kocaeli City Hospital