Randomised comparative evaluation of midline approach and right molar approach for time for successful oral endotracheal intubation with flexible fiberoptic bronchoscope
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Total duration of time taken for intubation
研究概览
简要总结
In GROUP A, the patient’s table will be lowered to the minimum height . A pillow will be retained
under the occiput. After 4 minutes of neuromuscular blockade, a experienced anaesthesiologist will
position themselves at the head end of the patient to conduct fiberoptic bronchoscopy.
The fiberoptic bronchoscope will be held in the experienced anaesthesiologist’s left hand, while the
scope sheath will be grasped between the index finger and thumb of the right hand. The mouth will
be slightly opened using the ring finger of the right hand. Lingual traction maneuvers will be
performed with the assistance of a trained assistant, who will place a gauze over the tongue and
retract it manually.
The fiberoptic bronchoscope will be gradually inserted into the oral cavity using a midline approach
toward the glottis, maintaining the scope in a midline position. The time from the removal of the face
mask to the first view of the glottis (T1) will be recorded. As the scope tip approaches the epiglottis,
the glottis view will be assessed and graded according to the POGO score
In GROUP B , the table height will be minimized, while a pillow remains positioned under the occiput.
Following a 4-minute period of neuromuscular blockade, a experienced anaesthesiologist will stand
at the head end of the patient to conduct fiberoptic bronchoscopy.
The fiberoptic bronchoscope will be held in the anaesthesiologist’s left hand, with the scope sheath
gripped between the index finger and thumb of the right hand. The mouth will be slightly opened
using the ring finger of the right hand. Cheek pull maneuvers will be executed with the assistance of
an assistant, who will place a J shaped stylet in the right cheek and retract it manually.
The fiberoptic bronchoscope will be inserted gradually into the oral cavity at the right molar
approach toward the glottis, keeping the tip of scope above right molar and advance scope along or
just near the right margin of tongue in the right molar approach. The time from the removal of the
face mask (To) to the first view of the glottis (T1) will be noted. As the scope tip nears the epiglottis,
the glottis view will be assessed and graded according to the POGO score.
After T2, in both groups, the tip of the fiberoptic bronchoscope will be advanced beyond the
glottis into the trachea. Upon nearing the bifurcation of the trachea, visualization of the
carina will be confirmed, and further advancement will be halted. The endotracheal tube will
be rail loaded over the fiberoptic bronchoscope, ensuring the tube tip is positioned in the
mid-trachea. Subsequently, the fiberoptic bronchoscope will be removed, and the cuff of the
endotracheal tube will be adequately inflated. Anaesthesia circuit will be connected
immediately to ETT connector followed by controlled mode of mechanical ventilation
with tidal volume around 250-300 ml and frequency 20/min. Time taken for
appearance of end tidal carbon dioxide (EtCO2) on the capnograph will be noted (T2)
and total intubation time will be calculated (T3=T1+T2) The endotracheal tube will be
secured in place with tape. Fibre-scopy will be performed to assess and note any
injury to the oropharynx & larynx. Surgery will be proceeded as per the requirement
of Patient.
â— In both the groups attempt will be abandoned if oxygen saturation falls below 97
percent or time taken for single attempt exceeds 3 minutes.
A maximum of three attempts will be taken for successful intubation. If unsuccessful
then subsequent alternative airway management technique such as laryngeal mask
airway, video-laryngoscopy or direct laryngoscopy will be performed to secure
definitive patent airway as per Difficult Airway guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA grade – I and II Age group 18-60 years.
- •Healthy and intact teeth MMPG grade I and II Normal neck movement Normal upper lip bite test.
排除标准
- •Absent or loose teeth Artificial denture BMI more than 30 Kg/m2 Cervical spine disease Temporomandibular joint abnormalities.
结局指标
主要结局
Total duration of time taken for intubation
时间窗: T3 at baseline
次要结局
- 1. Time taken to achieve first laryngeal view T1(2. Time taken from first laryngeal view (T1) till capnographic)
研究者
Dr. Pradeep
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi
