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

NCT ID: NCT04109898

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-07
• Study Completion Date: 2020-03-19

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.

Conditions

Airway Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

standard I-gel insertion technique

Investigator will apply the recommended (standard) I-gel insertion technique in patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Modified I-gel insertion technique

Investigator will apply the modified (interventional) I-gel insertion technique in patients

Group Type: EXPERIMENTAL

Supraglottic airway device (I-gel) insertion

Intervention Type: DEVICE

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

Interventions

Supraglottic airway device (I-gel) insertion

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dileep Kumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

dileep kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

2019-1878-4900.

Identifier Type: -

Identifier Source: org_study_id