Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- adverse airway events
Study Overview
Brief Summary
Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique
Detailed Description
The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.
Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.
Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA I and II patients.
- •Age 16 years to 60 years.
- •Patient scheduled for elective surgical procedure.
Exclusion Criteria
- •Gastroesophageal reflux disorders
- •Obesity BMI more than
- •Pregnancy
- •Reactive airway disease/asthma
- •Patients with mallampati score III & IV
- •Anticipated difficult airway
- •Emergent surgery.
- •Known allergic to isoflurane and propofol.
Arms & Interventions
standard I-gel insertion technique
Investigator will apply the recommended (standard) I-gel insertion technique in patients
Modified I-gel insertion technique
Investigator will apply the modified (interventional) I-gel insertion technique in patients
Intervention: Supraglottic airway device (I-gel) insertion (Device)
Outcomes
Primary Outcomes
adverse airway events
Time Frame: 5 minutes
All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.
Secondary Outcomes
- adverse airway events(60 minutes)
Investigators
Dileep Kumar
Assistant Professor
Aga Khan University