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

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

Study Overview

• Status: Completed
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: Supraglottic airway device (I-gel) insertion

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard I-gel insertion technique; Investigator will apply the recommended (standard) I-gel insertion technique in patients
EXPERIMENTAL: Modified I-gel insertion technique; Investigator will apply the modified (interventional) I-gel insertion technique in patients	Device: Supraglottic airway device (I-gel) insertion; Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse airway events	All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse airway events	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.	60 minutes

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 19, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: anaesthesia; airway management; I-gel
• Other Study ID Numbers: 2019-1878-4900.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No