Comparison of the Standard Awake and Head elevated No touch technique of extubation to prevent respiratory complications during emergence from general anaesthesia in paediatric patients: A randomised controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe cough using the
研究概览
简要总结
Patients can be awake or deeply sedated when having tracheal extubation. Both approaches have their advantages and disadvantages. The disadvantage of deep extubation is aspiration, upper airway obstruction and laryngospasm. The advantages of head elevated lateral position are fewer episodes of desaturation, decreased upper airway obstruction and less chance of aspiration. Several harmful respiratory side effects and derangements in hemodynamic parameters may occur during emergence from general anaesthesia. Pediatric populations experience these occurrences more frequently. Cough is one of the more frequent side effects of the respiratory system, particularly in children.In this study we compare standard awake technique of extubation in supine position with "Head elevated No touch technique in lateral position" method of extubation,where patients are kept in a lateral position with 15-degree head elevation. No Touch refers to avoidance of any tactile stimulation until the spontaneous opening of eyes occurs. We expect that the “Head elevated No touch technique†of extubation in lateral position would be a better technique of extubation in the prevention of respiratory side effects like choking, laryngospasm, posterior tongue drop, Breath holding and hypoxemia (Spo2 < 94%) compared to “Standard Awake technique†of extubation in supine position in the paediatric population, thus providing a better alternative method extubation in the paediatric population (less than five years of age).
Parameters that will be recorded in this study are following:
1.Incidence of moderate to severe cough using the Modified Minogue scale.
2.Incidence of other respiratory adverse effects like choking, laryngospasm, posterior tongue drop, Breath holding and hypoxemia (Spo2 < 94%).
3.The changes in hemodynamic parameters (Mean Blood Pressure, Heart Rate and Respiratory Rate).
4.Sedation agitation score after extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status 1,2 and 3 2) Age ≤ 5 years 3) Weight ≤ 20 kg.
排除标准
- •1.Refusal by the guardian 2.Anticipated difficult airway including Mallampati classification mandibular protrusion movement disorder of atlanto-occipital joint increased tongue thickness reduced mandibular space and abnormal thyromental distance 3.Children who had previously failed conventional direct laryngoscopy 4.Duration of surgery less than 1 hours 5.History of cardiopulmonary disease and Recent upper respiratory infection (less than two week) 6.Continuous treatment for allergic rhinitis asthma obstructive sleep apnea or severe snoring 7.Weight-for-height greater than 3 standard deviations above WHO Child Growth Standards median 8.other factors includes Patient posted for emergency procedures, Head and Neck surgery 9.Any surgical procedure with expected postoperative ICU admission.
结局指标
主要结局
Incidence of moderate to severe cough using the
时间窗: T1-Immediately after extubation | T2-1 minute after extubation | T3-10 minutes after extubation
Modified Minogue scale
时间窗: T1-Immediately after extubation | T2-1 minute after extubation | T3-10 minutes after extubation
次要结局
- 1.Mean Blood Pressure(2.Heart Rate)
研究者
Gokul Rangan
All India Institute of Medical Sciences, Patna