CTRI/2024/09/073235尚未招募不适用
Periperative respiratory adverse events during deep versus awake extubation in pediatric patients - a single centered prospective randomized control trial
未提供1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2024年9月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Major airway complications at emergence that will be recorded are desaturation, laryngospasm, bronchospasm, regurgitation, stridor, persistent coughing, negative pressure pulmonary edema.
研究概览
简要总结
Tracheal extubation is a critical event during emergence from anesthesia and the complications arising at extubation may lead to significant morbidity. Aim of this study is to compare the incidence of airway complications between awake and deep extubation with respect to major perioperative respiratory adverse events. Study will be prospective randomised controlled trial and will be conducted in children posted for short duration urological and general surgery procedures.
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
- 6.00 Month(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Asa 1 and 2 patients posted for elective abdominal and urological procedures of less than 4 hours duration.
排除标准
- •Children less than 60 weeks post conceptional age, reactive airway disease, full stomach and high risk of aspiration, severe OSA, BMI more than 95 or less than 5th centile, craniofacial anomaly, any trauma or difficult airway, hemodynamic or metabolic abnormality.
结局指标
主要结局
Major airway complications at emergence that will be recorded are desaturation, laryngospasm, bronchospasm, regurgitation, stridor, persistent coughing, negative pressure pulmonary edema.
时间窗: 1 year
次要结局
- Incidence of minor airway complications like cough, breath holding, increased airway secretions, tube biting and minor airway obstruction.(Other parameters are hemodynamic variations, emergence delerium, need of oxygen and airway support in PACU,need for admission in ICU)
研究者
Raylene Dias
Seth GSMC and KEM hospital
研究点 (1)
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