To compare two devices for managing airway during anaesthesia in adult patients undergoing laparoscopic gall bladder surgery.
- Conditions
- AGE more than 18YEARS ASA GRADE I AND II
- Registration Number
- CTRI/2020/04/024856
- Lead Sponsor
- Vardhman Mahavir Medical college and Safdarjung Hospital
- Brief Summary
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 p**regnancywill 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) .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 100
1)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,.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the ease of intubation which include: 1.Time for achieving effective airway (seconds), 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 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 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. 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.
- Secondary Outcome Measures
Name Time Method 1) Cormack lehane grade 2) Maximum drop in saturation 3) Mucosal or dental trauma 4) Rescue intubation used or not
Trial Locations
- Locations (1)
Vardhman Mahavir Medical college and Safdarjung Hospital
🇮🇳Delhi, DELHI, India
Vardhman Mahavir Medical college and Safdarjung Hospital🇮🇳Delhi, DELHI, IndiaDr Anand Kumar SinghPrincipal investigator8860887856anandkumarsingh88@gmail.com