Comparative evaluation of two supraglottic devices in patients undergoing elective surgery under general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insertion time
研究概览
简要总结
Rationale: Ambu AuraGain (AAG) and LMA ProSeal (PLMA) are supraglottic devices which can be used for controlled ventilation during general anaesthesia. However, there is limited literature comparing the two devices with contradictory results on the time and ease of insertion of these devices.
Aim: To compare and evaluate insertion characteristics of Ambu AuraGain with LMA ProSeal in patients undergoing elective surgery under general anesthesia.
Primary Objective
To compare the time taken for successful insertion of Ambu AuraGain with LMA ProSeal.
Secondary objectives
To compare Ambu AuraGain with LMA ProSeal in terms of:
Ease of device insertion.
Number of attempts for successful insertion.
Success rate in first insertion attempt
Ease of insertion of gastric tube.
Haemodynamic changes.
Ease of removal and complications during removal.
Postoperative airway complications.
Setting: The study will be conducted in the Department of Anaesthesiology, Critical Care and Pain Medicine UCMS and GTB Hospital (University of Delhi).
Study design: Randomized comparative study.
Time frame: November 2018 to April 2020
Population / participants: Patients of either sex, between 18-60 years ASA grade I/II with Modified Mallampatti class I/II who are fasting for at least 8 hours and have BMI <30kg/m2, undergoing any elective surgical procedure under general anaesthesia requiring supraglottic airway device insertion.
Exclusion criteria:
Patients with restricted mouth opening (< 3cm)
Pregnant women.
Known case of chronic obstructive pulmonary disease, Asthma or any other restrictive or obstructive respiratory pathology.
History of gastroesophageal reflux disorder.
History of esophagectomy, hiatal hernia and any intraoral growth.
Sample size: 20 patients in each group, a total of 40 patients.
Methods:
The patients will be assigned to one of two groups using computer generated random number table.
Group AAG: Ambu AuraGain will be inserted as airway maintenance device
Group PLMA: LMA ProSeal will be inserted as airway maintenance device.
After inducing general anaesthesia either AAG or PLMA will be inserted according to randomisation. Proper placement will be confirmed by auscultation, ETCO2 values. Parameters like Insertion time, Ease of insertion, Ease of gastric tube placement, Haemodynamic variables (SBP, DBP, HR), use of manoeuvres, Number of attempts and rate of successful placement by either technique, Incidence of sore throat and failure of device insertion will be recorded.
Outcome measures:
Ease of device insertion.
Number of attempts for successful insertion.
Success rate in first insertion attempt
Ease of insertion of gastric tube.
Hemodynamic changes. (HR, SBP, DBP)
Ease of removal and complications during removal.
Postoperative airway complications.
Statistical Analysis:
One time measured quantitative parameters which follow the normal distribution will be compared using unpaired Student’s t-test and those which are non-normally distributed will be analyzed using Mann Whitney ‘U’ test. The qualitative parameters will be compared using Chi-square / Fisher’s exact test.
A p-value of <0.05 will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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/II with Modified Mallampatti class I/II who are fasting for at least 8 hours and have BMI <30kg/m2, undergoing any elective surgical procedure under general anaesthesia requiring supraglottic airway device insertion.
排除标准
- •Patients with restricted mouth opening (< 3cm) Pregnant women.
- •Known case of chronic obstructive pulmonary disease, Asthma or any other restrictive or obstructive respiratory pathology.
- •History of gastroesophageal reflux disorder.
- •History of esophagectomy, hiatal hernia and any intraoral growth.
结局指标
主要结局
Insertion time
时间窗: Once, after device insertion.
次要结局
- gel plug test(Once, after device insertion)
- Ease of insertion(Once, after device insertion)
- Number of attempts for successful insertion(Once, after device insertion)
- Ease of gastric tube placement(Once, after gastric tube insertion)
- Hemodynamic variables and Ventillatory parameters(HR, SBP, DBP, SPO2, EtCO2)(Baseline, 0mins, 1min, 5mins, 10mins, at the time of removal, 5mins post removal)
- Us of manoeuvres(once, after device insertion)
- Sore throat incidence.(2hrs post operatively.)