Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to discharge from PACU
研究概览
简要总结
Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).
详细描述
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient（tidal volume >6-8 ml/kg, respiratory rate >10 times per minutes , end tidal carbon dioxide concentration >7.19 mmHg）, the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status aged 3-7 years
排除标准
- •a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index>30 kg/m2
结局指标
主要结局
Time to discharge from PACU
时间窗: The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour
Time to discharge from PACU
Time to spontaneous eye opening
时间窗: The time from PACU arrival to spontaneous eye opening, an average of 45 min
Time to spontaneous eye opening
Coughing
时间窗: at the time of extubation within 1 minute
1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 \<95%; and 4 if multiple coughs occurred, SpO2 \<95%, and coughing required administration of i.v . medication.
Respiratory complications
时间窗: During the time when patients stayed in PACU after extubation, an average of 45 min
the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2\<90%
次要结局
- Heart rate(5 minutes after extubation)
- Age(6 hours before intervention)
- Height(6 hours before intervention)
- Diastolic blood pressure(5 minutes after extubation)
- Time to extubation(The time from PACU arrival to tracheal extubation, an average of 30 min)
- End-tidal concentration of minimum effective alveolar anesthetic concentration(The time before patients were decided to extubate, within 1 minute)
- Weight(6 hours before intervention)
- Systolic blood pressure(5 minutes after extubation)