Videolaryngoscopic versus Direct Laryngoscopic Paraglossal Intubation for Cleft Lip/Palate Reconstructive Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate.
研究概览
简要总结
This study will be a randomized control trialconducted in the Post Graduate Institute of Medical Education and Research,Chandigarh between January, 2018 and October 2018. It will include paediatricin-patients with uncorrected cleft lip/palate posted for elective reconstruction surgeries. The sample size of 80 will be block randomized into 20 groups of 4 each.It will compare the reduction in difficult laryngoscopy performed by the paraglossal technique using the Videolaryngoscope versus the direct laryngoscope. The primary outcome will be to assess the first pass intubation rate using thevideolaryngoscope versus the direct laryngoscope in intubating by the leftparaglossal approach. The secondary outcomes will be to assess the time taken for successfulendotracheal intubation and the intubation difficulty score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with uncorrected cleft lip/palate.
- •Patients posted for elective cleft lip/palate reconstructive surgery.
排除标准
- •Parents/guardians who do not give consent.
- •Patients who have difficulat bag and mask ventilation.
- •Patients with supraglottic mass lesions.
- •Patients with hemodynamic instability.
- •Patients with recent upper respiratory tract infections.
- •Patients with coagulation disorders.
结局指标
主要结局
To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate.
时间窗: To assess the first pass intubation rate using the videolaryngoscope versus the direct laryngoscope in intubating by the left paraglossal approach in paediatric patients undergoing corrective surgeries for cleft lip/palate after confirmation of successful endotracheal intubation by waveform capnography.
次要结局
- Intubation difficulty score(During laryngoscopy and post intubation.)
- Time taken for successful endotracheal intubation(Time taken from removal of facemask to confirmation of correct endotracheal tube placement by waveform capnography.)