Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Respiratory instability
研究概览
简要总结
Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events. We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 years - 18 years
- •Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
- •Informed consent/assent for enrollment by parents/legal guardians/patient
排除标准
- •Congenital or acquired malformations involving the airways
- •Patients with the history of spontaneous pneumothorax or connectives tissue diseases (Marfan syndrome, Ehlers-Danlos-Syndrome)
- •Patients with a history of traumatic/iatrogenic air leak within the last 3 months before enrollment
研究组 & 干预措施
Standard care
Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
干预措施: Standard respiratory care (Other)
High Flow nasal cannula
Application of humidified heated ambient air with flow rates adapted to body weight of respective subject. Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).
干预措施: High Flow nasal cannula (Other)
结局指标
主要结局
Respiratory instability
时间窗: Time frame from first applications of intravenous sedatives until finishing the intended procedure
Number of episodes longer than 15 seconds with SpO2 \< 93% and/ or pCO2 \> 45 mmHg and/ or apnea (defined as cessation of airflow for \> 15 seconds)
次要结局
- Number of interventions to regain respiratory stability(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Duration of respiratory instability(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Need for noninvasive ventilation(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Use of sedatives(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Use of analgesics(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Time of procedure in minutes(Duration of the procedure for which sedation is determined. It covers the time period from first positioning of the patient to repositioning of the patient or patients extremities after completion of the procedure)
- Time of sedation in minutes(Time frame from first applications of intravenous sedatives until finishing the intended procedure)
- Nausea and vomiting(24 hours after procedural sedation)
研究者
Daniel Klotz
M.D.
University of Freiburg