A randomized comparative study to compare AIR-Q vs AMBUAURAGAIN as conduit for blind tracheal intubation using microcuff tube in pediatric patient under general anesthesia in Department of Anesthesia, SMS Medical college, Jaipur
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
- To evaluate first attempt success rate of blind tracheal intubation through AIR-Q and AMBUAURAGAIN using microcuff tube in pediatric patient.
研究概览
简要总结
Patient satisfying inclusion criteria and PAC fitness will be selected and taken into
OT. Patient will be identified, fasting status and take informed written consent will be
checked. Randomization will be done using sealed envelope method and the type of tube
will be selected. Group A airway will be secured with AIR_Q ILA then intubated with
microcuff ET Tube (n=50) and Group B airway secured with AMBUAURAGAIN and
then intubated with microcuff ET Tube (n=50)
Routine monitors will be attached, vitals will be monitored continuously.
Baseline vitals like Non-invasive blood pressure(NIBP), pulse rate(PR), oxygen
saturation(SpO2), will be noted. Intravenous fluid will be started as per hospital protocol
in already secured peripheral IV line.
Inj. Glycopyrrolate (0.005 mg/kg)IV +Inj.midazolam(0.05mg/kg)IV given. Inj.
Fentanyl (2mcg/kg) will be given as analgesic
After preoxygenation with 100% O2,Induction of anaesthesia will be done with
Inj. Propofol (2.5-3mg/kg).Relaxation will be obtained with Inj. Atracurium 0.5mg/kg
and patient will be ventilated for 3 minutes with 5L of oxygen.
LMA will be introduced into the patient and cuff will be inflated with appropriate amount
of air ( max 10ml). Correct placement of LMA will be confirmed with bilateral chest
inflation, a square wave capnogarphy and fibreoptic bronchoscopy.
A lubricated microcuff endotracheal tube either AIR-Q ILA in group A or
AMBUAURAGAIN group B will be inserted . Cuff will be inflated to the desired level.
Correct placement of endotracheal tube in the trachea will be confirmed with equal
bilateral air entry and capnograph tracing.
After successful ET tube insertion, the LMA will be deflated and removed while
the ET Tube will be secured. Anaesthesia will be maintained with inhaled sevoflurane
2%+ 60%N2O+40%O2 and Inj. atracurium 0.1mg/kg (maintenance dose).
HR, SpO2, NIBP and EtCO2 will bemonitored continuously during the procedure.
Post operative complication like post extubation cough, stridor and laryngospasm
will be recorded in the immediate post- operative period and one hour after extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade 1 and 2 2)Undergoing elective surgery requiring endotracheal intubation 3)Parent/guardian willing to provide consent for participation.
排除标准
- •Abnormal airway anatomy assessed by – passive mouth opening, micrognathia, thyromental distance, and submental compliance, intra oral growth.
- •Patient with cardiopulmonary disease
- •Severe gastrointestinal reflux 4.History of upper respiratory tract infection in previous 14 days.
- •5.Patient should not be part of other study
- •Non co-operative patient.
结局指标
主要结局
To evaluate first attempt success rate of blind tracheal intubation through AIR-Q and AMBUAURAGAIN using microcuff tube in pediatric patient.
时间窗: To assess and compare intubating characteristics of AIR-Q versus AMBUAURAGAIN in terms of: | 1.Time taken for intubation. | 2.Number of attempts for blind tracheal intubation. | 3.Maneuver applied for intubation. | 4.Time taken for removal of device after intubation is accomplished.
次要结局
- To assess and compare insertion characteristics of AIR-Q versus AMBUAURAGAIN in terms of:(1)Time taken in insertion of devices.)
研究者
Dr Neelam Dogra
Sawai man singh medical college and attached hospitals jaipur