跳至主要内容
临床试验/CTRI/2024/09/074234
CTRI/2024/09/074234尚未招募2/3 期

Randomised comparative evaluation of midline approach and right molar approach for time for successful oral endotracheal intubation with flexible fiberoptic bronchoscope

未提供1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年10月4日最近更新:

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.

● 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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr. Pradeep

ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi

研究点 (1)

Loading locations...

相似试验