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临床试验/CTRI/2020/04/024856
CTRI/2020/04/024856招募中Unknown

A comparative evaluation of clinical efficacy of two supraglottic airway devices in adult patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Vardhman Mahavir Medical college and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月25日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds),

研究概览

简要总结

Theimportance and prevalence of supraglotticairway devices (SGDs) in airway management has increasedconsiderably in recent years. The second generation supraglottic airway devicessuch as Laryngeal mask airway Proseal,  i-gel and Laryngealmask airway Supreme have overcome the limitations of cLMA . They comewith an inbuilt gastric drainage tube to empty stomach contents and aredesigned to provide better airway protection and higher oropharyngeal sealpressures as compared to first generation devices. These devices are a reasonable alternative choice toendotracheal intubation when performing anesthesia for procedures accompaniedby high peak airway pressure, such as laparoscopic surgery. There is paucity of comparativestudies between Ambu AuraGain and i- gel in literature. Therefore, inthis study we will evaluate and compare clinical efficacy of Ambu AuraGain withi-gel as a ventilatory device in patients undergoing laparoscopiccholecystectomy under general anaesthesia with controlled ventilation. This study will be conducted in 80adult patients of 18 to 60 years of age, of either gender, American society of Anaesthesiologists (ASA) physicalstatus I and II, weighing 30 to 70 kg, undergoing elective laparoscopiccholecystectomy surgery under general anaesthesia with controlled ventilationin supine position.

Patients with anticipated difficult airway, cervicalspine pathology**,** operation timegreater than 4 hours**,** high risk ofaspiration, preoperative sore throat**,** poordentition with high risk of damage and pregnancywill be excluded. Block randomization in series of blocks of ten will be doneto allocate patients to two groups of 40 each based on sealed envelope method.  After standard anesthesia technique the twodevices will be inserted by standard technique an anesthesiologist who hasexperience of more than 30 successful insertion with both the devices. Airwaymanipulations such as jaw thrust or lateral rotation of device while insertingthe device, head and neck flexion or extension, chin lift and change in thedepth of device needed for achieving effective airway will be noted. Achieving both aneffective airway and a successful insertion of gastric tube will beconsidered as a successful insertion of the device. The following parameterswill be recorded oropharyngeal leakpressure after insertion of device , number of attempts, time for achievingeffective airway, number of patients requiring manipulation, ease of insertionof device, ease of gastric catheter insertion, anatomical alignment of device,leak percen**t (**percentage lossof set inspiratory volume) and adverse events if any. A p valueof <0.05 will be considered statistically significant.The data will be entered in MS EXCELspreadsheet and analysis will be done using latest version of StatisticalPackage for Social Sciences (SPSS) .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 18 to 60 years of age 2)Either gender 3)American society of Anaesthesiologists (ASA) physical status I and II 4)Weight 30 to 70 kg,.

排除标准

  • Anticipated difficult airway including: Thyromental distance <6.5 cm, upper lip bite test more than grade 1, Mallampati class III and IV, restricted head and neck mobility, inter incisor gap <3.5cm , BMI>30 kg/m2 2) Cervical spine pathology 3) Operation time greater than 4 hours 4) High risk of aspiration ( gastroesophageal reflux disease) 5) Preoperative sore throat 6) Poor dentition with high risk of damage,loose teeth, edentulous patient 7)Pregnancy.

结局指标

主要结局

To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds),

时间窗: To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds), | 2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5 | 3.Manipulation for achieving effective airway – yes/no | 4.No of attempts - 1/2/3/ failure.

2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5

时间窗: To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds), | 2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5 | 3.Manipulation for achieving effective airway – yes/no | 4.No of attempts - 1/2/3/ failure.

3.Manipulation for achieving effective airway – yes/no

时间窗: To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds), | 2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5 | 3.Manipulation for achieving effective airway – yes/no | 4.No of attempts - 1/2/3/ failure.

4.No of attempts - 1/2/3/ failure.

时间窗: To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds), | 2.Ease of insertion of device: Score 1/ 2/ 3/ 4 / 5 | 3.Manipulation for achieving effective airway – yes/no | 4.No of attempts - 1/2/3/ failure.

次要结局

  • 1) Cormack lehane grade 2) Maximum drop in saturation 3) Mucosal or dental trauma 4) Rescue intubation used or not

研究者

发起方
Vardhman Mahavir Medical college and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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