Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia: A Pilot Randomised Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Time to first event
研究概览
简要总结
Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in children.
This was a pilot randomised controlled trial. Patients were randomised to either receive apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome was the duration of safe apnoea, defined as a composite of the time to first event, either time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2 observed during airway management. Secondary outcomes were number of patients whose SpO2 dropped below 95% and number of patients whose SpO2 dropped below 92%.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were included who were scheduled for elective surgery under general anaesthesia.
- •Age: one eight years old.
- •ASA I and II only.
- •Patients with normal cardiorespiratory function.
排除标准
- •Children undergoing dental surgeries in which nasal intubation is needed.
- •Patients who suffered from quick drops in oxygen saturation more rapidly than healthy children due to different reasons such as: respiratory and pulmonary diseases, active or recent upper respiratory tract infection, syndromes with cardiopulmonary pathologies, cardiac anomalies, anaemia, depressed respiratory effort, ventilation/perfusion imbalance, Obstructive Sleep Apnoea (OSA), and airway obstruction.
- •Patients reported with nasal obstruction.
- •Patients with grades of laryngoscopic view (Cormack Lahane) greater than II, which indicates upper airway obstruction.
研究组 & 干预措施
Apnoeic oxygenation group
Standard airway management + 3 L/min of oxygen by nasal cannula
干预措施: Apnoeic oxygenation (Device)
Standard care group
Standard airway management
结局指标
主要结局
Time to first event
时间窗: Estimated: 10 seconds to 3 minutes
Time to first event: either time for SpO2 to fall to 92% or time to successfully secure the airway as usual practice without allowing desaturation
The lowest SpO2 observed during airway management
时间窗: Estimated: 10 seconds to 3 minutes
The lowest SpO2 observed during airway management
次要结局
- Number of patients whose SpO2 dropped below 95%(Estimated: 10 seconds to 3 minutes)
- Number of patients whose SpO2 dropped below 92%(Estimated: 10 seconds to 3 minutes)
研究者
Lafi Olayan
Research fellow
University of Birmingham