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A study comparing three ways of placing a soft breathing device during anesthesia.

Comparative evaluation of three different techniques (standard, reverse and rotation) of I-Gel insertion in patients undergoing surgery under General Anaesthesia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097668
Enrollment
264
Registered
2025-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: Z00-Z13- Persons encountering health services for examinations

Interventions

Intervention1: Standard: Igel insertion using standard technique - The conventional method where the the device is inserted along the hard palate in the neutral head position. Control Intervention1: R

Sponsors

Swami Dayanand Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA Physical Status I and II Mallampati Class I II BMI 18 25 kg/m Elective surgeries requiring general anaesthesia Surgeries in supine position

Exclusion criteria

Exclusion criteria: Predicted difficult airway (Mallampati III/IV, restricted mouth opening, limited neck mobility) Risk of aspiration (full stomach, GERD, pregnancy) Upper respiratory tract infection or recent sore throat Emergency surgeries

Design outcomes

Primary

MeasureTime frame
To compare the first-attempt success rate of i-GEL insertion using the standard, reverse, and rotational techniques.Timepoint: At the time of insertion

Secondary

MeasureTime frame
To compare the time taken for i-GEL insertion among the three techniques. To compare the oropharyngeal leak pressure (OLP) achieved with each technique. To compare the fiberoptic view of placement with each technique. To compare the ease of placement of orogastric tube with each technique. To compare the incidence of insertion-related complications, including blood staining, cough and sore throat at 1 hour and 24 hours. Timepoint: At the time of insertion, during surgery and after surgery

Countries

India

Contacts

Public ContactSivagurunathan

Swani Dayanand hospital

sonalsharma921@gmail.com9650637028

Outcome results

None listed

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