Safety and efficacy of two different methods of endotracheal tube cuff inflation in children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To compare percentage of intracuff pressure within recommended range (20-30 cm of H2O) in both groups
研究概览
简要总结
Cuffed endotracheal tubes are considered standard of care in children <8 years of age. Pre-requisite is to maintain intra-cuff pressure<30 cm of H2O.Measurement of cuff pressure by manometer is gold standard but not feasible in every clinical scenario with high turnover rate. Best practical solution is to inflate cuff just enough to achieve adequate seal. So the study will compare and objectively justify two different methods of cuff inflation (Manual palpation, Stethoscope guided removal of air) in terms of achieving minimal intra-cuff pressure with adequate seal. A prospective double blind, randomized, paralleled ,active controlled study will recruit children of 3-8 years undergoing surgery under general anaesthesia using endotracheal tube. Intra-cuff pressure will be measured by AMBU manometer. Adequacy of seal will be ensured by supraglottic capnometry. Statistical analysis will be done using ANNOVA test, chi-square and fischer exact test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •All children of 3-8 years of age, of either sex, ASA grade I/II posted for open urogenital surgery lasting for duration of 1-4 hrs under general anaesthesia using endotracheal intubation.
排除标准
- •1.Patients with predicted difficult airway, airway abnormalities,reactive airway 2.Patients with lung disease, risk of pulmonary aspiration,requiring prolonged ventilation 3.Patients with previous sore throat, hoarseness of voice, respiratory infection in last one week,surgery requiring airway manipulation.
- •4.Not willing to participate 5.Patients requiring nitrous oxide as anaesthesia gas 6.Not fitting endotracheal tube size as selected by Duracher formula(age/4+3.5).
结局指标
主要结局
To compare percentage of intracuff pressure within recommended range (20-30 cm of H2O) in both groups
时间窗: Initially and after supraglottic capnometry
次要结局
- To compare airway morbidity related to overinflation of cuff like sore throat (assessed at 4 and 6 hrs postoperatively) stridor, croup, laryngospasm (assessed in immediate postoperative period) in both groups.(Immediately,4 and 6 hours after surgery)
研究者
Noopur Jani
Institute of Kidney Disease and Research centre,Institute of Transplantation Sciences,Ahmedabad