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临床试验/CTRI/2024/12/078399
CTRI/2024/12/078399尚未招募不适用

Comparison of Videolaryngoscope, McCoy laryngoscope and Intubating Laryngeal Mask Airway for oro-tracheal intubation in simulated cervical spine immobilization: A Prospective Randomized Comparative Study

dr manoj dean and director1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
to measure intubation success rate.

研究概览

简要总结

All the patients will be kept nil per oral overnight andpremedicated with tablet pantoprazole 40 mg and tab ondansetron 4mg orally 2hrs prior to the surgery. In the operation theater, electrocardiogram, noninvasive blood pressure, and pulse oximeter will be attached and baseline readings will be noted. An adequate gauge intravenous (i.v.) cannula will be secured and i.v. fluid started. The patient will bepreoxygenated with 100% oxygen for 3 min. General anesthesia will be induced with fentanyl 2 µg.kg −1 body weight followed by propofol 2–2.5 mg.kg −1 body weight and vecuronium bromide 0.1 mg.kg −1 body weight to facilitate endotracheal intubation. Mask ventilation will be done with oxygen (FiO2 1) and isoflurane (MAC 0.6). Patient’s head and neck will be immobilized in the neutral position using appropriate size rigid Philadelphia cervical collar. [3]

After 3 min, oral intubation will be performed using the assigned device by anexperienced anesthesiologist, who has conducted at least 100 successful intubations using these devices.

As per group allocation intubation will be performed using one of the three devices. In group VL, blade will be inserted in the midline in the oral cavity and advanced under its monitor vision till its tip reached vallecula. The epiglottis is then lifted to visualize the glottic opening. A cuffed reinforced endotracheal tube (ETT) of internal diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will be introduced. Correct placement of ETT is confirmed by the appearance of square wave capnographic trace, bilateral equal breath sounds, and absence of epigastric sounds.

In group MC, MAC COY blade will be inserted in the midline in the oral cavity and advanced till its tip reached vallecula. The epiglottis is then lifted to visualize the glottic opening. A cuffed reinforced endotracheal tube (ETT) of internal diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will be introduced.

Stylet or bougie will be used for intubation if needed in the above two groups, and will be noted.

In group IL, the correct size of ILMA will be selected according to patient’s body weight: 30–50 kg: ILMA number 3, ILMA tube 7.0 mm; 50–80 kg: ILMA number 4, ILMA tube 7.5 mm. The cuff of ILMA is partially deflated using deflator and upper surface of its mask is lubricated. Mouth is opened using nondominant hand and ILMA inserted by dominant hand. The cuff of ILMA is inflated with the requisite amount of air (size 3: 20 ml, size 4: 40 ml, and size 4: 50 ml) and adjusted to get optimal ventilation. [6] After confirming the presence of bilateral equal entry and a square wave capnograph, intubation will be done with lubricated ILMA ETT. The cuff of ILMA ETT is inflated and intubation confirmed by visualizing square wave capnograph and bilateral air entry. The ILMA cuff is deflated, and ILMA is swung out of the pharynx into the oral cavity while applying counter pressure to the tracheal tube using the stabilizing rod. The ETT connector is replaced and tube placement reconfirmed using a square wave capnograph. Either of the following maneuvers is used for troubleshooting any difficulty in intubation through the ILMA: rotation of ILMA ETT, reinsertion of ILMA ETT, and reinsertion of ILMA of same or smaller or larger size. [6]

Hypoxemia is defined as fall in SpO2 up to or below 92%. In case of failure to intubate with the given device in any of the group within two attempts, patient’s trachea is intubated using macintosh laryngoscope after removing the cervical collar and will be excluded from the study. After rechecking the ETT position, patient is ventilated mechanically, and anesthesia will be maintained with isoflurane (0.6–0.8 MAC) in oxygen and nitrous oxide (FiO2 0.4).

研究设计

研究类型
Interventional
分配方式
Randomized
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 physical status classes I or II,scheduled for elective surgery under general anesthesia with endotracheal intubation.

排除标准

  • 未提供

结局指标

主要结局

to measure intubation success rate.

时间窗: o, 1, 3, 5 , 10 mins

Ease and success of oral endotracheal intubation were assessed by: a. number of attempts taken, max 2 attempts allowed b.Time taken for intubation c. Need for laryngeal maneuvers or stylet or bougie.

时间窗: o, 1, 3, 5 , 10 mins

次要结局

  • Hemodynamic parameters during the intubation procedure (baseline, preintubation, 1, 3, 5mins after intubation) b.(1, 3, 5 mins interval)
  • b. incidence of desaturation(1, 3, 5 mins)
  • Postoperative complications - Incidence of postoperative sore throat (1hr postoperative period) and Incidence of injury to teeth and other soft tissues.(end operative post extubation)

研究者

发起方
dr manoj dean and director
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr K B Nalini

SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE

研究点 (1)

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