Comparison of Air Q, I Gel and Baska mask in the anaesthetised patients

Recruiting

• Conditions: Scheduled for surgery in supine position under general anaesthesia with a total duration of less than one hour

• Registration Number: CTRI/2016/01/006498
• Lead Sponsor: PGIMER

Brief Summary

PRIMARY AIM: To compare the oropharyngeal leak pressure of all three airway device viz.,air-Q, i-gel, Baska mask

SECONDARY AIMS: To compare the ease ofinsertion of device, effective airway insertion time, rates of successfulinsertion, ease of gastric tube insertion, airway manipulations duringinsertion, hemodynamic changes, intra operative and post operative devicerelated oropharyngeal morbidities in anaesthetized non paralyzed adult patientsundergoing elective surgeries.

HYPOTHESIS: Baska would have higheroropharyngeal leak pressure compared to air Q and i-gel.

To determine the leak pressure,the expiratory valve will be closed with a fresh gas flow of 3 L/min untilequilibrium will be reached and then released completely (not allowed to exceed40 cm H2O). Presence or absence of gastric insufflations byepigastric auscultation will be performed during leak pressure testing.Gas leakage will be determined at the (1) mouth(audible), (2) the stomach (epigastric auscultation) or (3)the drainage tube(bubbling of lubricant placed on the proximal end of the drainage tube).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

ASA physical status I /II scheduled for surgery in supine position under general anaesthesia with a total duration of less than one hour will be included in the study.

Exclusion Criteria

• Gastro-esophageal reflux disease 2.
• PriorEsophagectomy 3.
• Hiatus hernia 4.
• Prior h/o of vomiting within 24hrs after surgery 5 .Known oropharyngeal morbidities 6.
• Full stomach with risk of aspiration 7.
• BMI>35kg/m2 8.
• Any condition which requires endotracheal intubation 9.
• Patientsunwilling to participate in study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oropharyngeal leak pressure of all three airway device viz., air-Q, i-gel, Baska mask	5 minutes after insertion of airway

Secondary Outcome Measures

Name	Time	Method
To compare the ease of insertion of device, effective airway insertion time, rates of successful insertion, ease of gastric tube insertion, airway manipulations during insertion, hemodynamic changes, intra operative and post operative device related oropharyngeal morbidities in anaesthetized non paralyzed adult patients undergoing elective surgeries.	Throughout duration of surgery

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Vikas Saini

Principal investigator

7087008119

drvsaini@gmail.com