Comparison of insertion of i-gel (airway device), with and without the use of tongue depressor, in patients requiring general anaesthesia

Comparison of insertion of I-Gel with and without the use of a tongue depressor in anaesthetised patients - A Randomised Controlled Trial - nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061813

Enrollment

130

Registered

2024-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z468- Encounter for fitting and adjustment of other specified devices Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Use of tongue depressor for Igel insertion: Insertion of Igel with the use of a tongue depressor (takes maximum 2 minutes) Control Intervention1: Igel insertion without tongue depressor

Eligibility

Inclusion criteria

Inclusion criteria: o BMI o Patients belonging to ASA PS I, II and III o Patients requiring anaesthesia for short surgeries.

Exclusion criteria

Exclusion criteria: o Patients undergoing emergency surgery o Risk of aspiration (full stomach) o Mouth opening of o Upper airway pathology precluding i-gel insertion o Known cervical spine disease

Design outcomes

Primary

Measure	Time frame
Rate of successful placement in the first attempt.Timepoint: Immediately after insertion of I-gel	—

Secondary

Measure	Time frame
2. The total time for securing airway will be from the time the face mask is removed to obtaining a square wave capnographic tracing.Timepoint: end of insertion of igel;3. The time for i-gel insertion will be from the time the i-gel was picked up until a good capnographic tracing noted.Timepoint: end of insertion of igel;4. The ease of insertion will be graded by Observer 2 on a scale as follows: 1 â?? Very easy, 2 â?? Easy, 3 â?? Slightly difficult, 4 â?? Very difficult, 5 - Not possible. Timepoint: end of insertion of igel;5. Number of attempts: An attempt is described as insertion of i-gel from the mouth into the pharynx. A total of two attempts will be permitted using the technique originally allotted. If not successful, a third attempt will be made by crossing over to the technique employed in the other group. If this also fails, it will be deemed unsuccessful. The patient will be excluded from the group for further analysis. The airway management will be according to the consultant anaesthesiologist posted on that case.Timepoint: end of insertion of igel;6. Manoeuvres used: The first insertion will be attempted with just the head extended and mouth open (with or without a tongue depressor as per group). If this fails, a jaw thrust is provided by Observer 3. If this fails, insertion of i-gel may be attempted using lateral technique (the i-gel is inserted sideways till mid-oral cavity is reached and then turned so that its concavity faces the tongue and the insertion is completed.Timepoint: end of insertion of igel;7. Haemodynamic changes: Blood pressure and heart rate will be noted at baseline, just before insertion of i-gel, and at 1 min, 3 min and at 5 min after.Timepoint: end of insertion of igel;8. Complications: The patients will be followed up for complications as follows: Visible trauma to the lips, tongue, blood on the device after removal (Yes, No), sore throat and hoarseness (none, mild, moderate, severe).Timepoint: 24 hours of intubation	—

Measure

Time frame

2. The total time for securing airway will be from the time the face mask is removed to obtaining a square wave capnographic tracing.Timepoint: end of insertion of igel;3. The time for i-gel insertion will be from the time the i-gel was picked up until a good capnographic tracing noted.Timepoint: end of insertion of igel;4. The ease of insertion will be graded by Observer 2 on a scale as follows: 1 â?? Very easy, 2 â?? Easy, 3 â?? Slightly difficult, 4 â?? Very difficult, 5 - Not possible. Timepoint: end of insertion of igel;5. Number of attempts: An attempt is described as insertion of i-gel from the mouth into the pharynx. A total of two attempts will be permitted using the technique originally allotted. If not successful, a third attempt will be made by crossing over to the technique employed in the other group. If this also fails, it will be deemed unsuccessful. The patient will be excluded from the group for further analysis. The airway management will be according to the consultant anaesthesiologist posted on that case.Timepoint: end of insertion of igel;6. Manoeuvres used: The first insertion will be attempted with just the head extended and mouth open (with or without a tongue depressor as per group). If this fails, a jaw thrust is provided by Observer 3. If this fails, insertion of i-gel may be attempted using lateral technique (the i-gel is inserted sideways till mid-oral cavity is reached and then turned so that its concavity faces the tongue and the insertion is completed.Timepoint: end of insertion of igel;7. Haemodynamic changes: Blood pressure and heart rate will be noted at baseline, just before insertion of i-gel, and at 1 min, 3 min and at 5 min after.Timepoint: end of insertion of igel;8. Complications: The patients will be followed up for complications as follows: Visible trauma to the lips, tongue, blood on the device after removal (Yes, No), sore throat and hoarseness (none, mild, moderate, severe).Timepoint: 24 hours of intubation

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Countries

India

Contacts

Public ContactPuja Mohapatra

Kasturba Medical College

anitharshenoy@gmail.com9880842121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026