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

Airway Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109898
• Other study ID #: 2019-1878-4900.
• Status: Completed
• Phase: N/A
• Start date: September 7, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: February 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 19, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• Supraglottic airway device (I-gel) insertion
Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse airway events	All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.	5 minutes
Secondary	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