Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults

Not Applicable

Completed

• Conditions: Airway Morbidity
• Interventions: Device: Supraglottic airway device (I-gel) insertion

• Registration Number: NCT04109898
• Lead Sponsor: Aga Khan University

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 Timeline

• Study Start: 2019-09-07
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 30.
• Pregnancy
• Reactive airway disease/asthma
• Patients with mallampati score III & IV
• Anticipated difficult airway
• Emergent surgery.
• Known allergic to isoflurane and propofol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified I-gel insertion technique	Supraglottic airway device (I-gel) insertion	Investigator will apply the modified (interventional) I-gel insertion technique in patients

Primary Outcome Measures

Name	Time	Method
adverse airway events	5 minutes	All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.

Secondary Outcome Measures

Name	Time	Method
adverse airway events	60 minutes	All study patients will be monitored forI-gel insertion complications such as an laryngospasm, hypoxemia (Sp02\<92%) and trauma to surrounding airway structures will be observe as blood stained I-gel at removal.

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan