Skip to main content
OpenTrials
Completed

NCT Number: NCT04109898

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supraglottic airway device (I-gel) insertion

Device

Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.

Primary outcomes

  1. 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

  1. adverse airway events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.