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Comparing two devices (I-gel versus I-gel plus) as a pathway for inserting breathing tube in patients undergoing operation

I-gel versus I-gel plus as a conduit for endotracheal intubation in elective surgical patients: A randomised comparative study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110974
Enrollment
72
Registered
2026-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: I-gel (group I): I-gel will be inserted for airway management. Endotracheal tube will be inserted through the I-gel. Control Intervention1: I-gel Plus (group P): I-gel Plus will be inse

Sponsors

Dr Anjali
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Elective surgery under general anaesthesia with supraglottic device forairway management 2. American Society of Anaesthesiologists (ASA) grade 1,2,3 3. Mallampati grade 1,2,3 4. Body Mass Index(BMI) 18.5 to 29.9 kilograms per meter square

Exclusion criteria

Exclusion criteria: 1. Anticipated difficult airway.Restricted mouth opening less than 3 centimetres 2. Limited neck mobility 3. Airway pathology 4. Recent upper airway surgery or bleeding 5. Pregnancy 6. Gastro esophageal reflux disease 7. Inadequate nil per oral time less than 6 hours

Design outcomes

Primary

MeasureTime frame
Time taken for successful endotracheal tube insertion through the supraglottic airway device (I-gel or I-gel Plus) among patients undergoing elective surgery. It will be calculated as the time from starting the endotracheal tube to confirmation of successful placement of endotracheal tubeTimepoint: 10 minutes after successful insertion of supraglottic airway device, before starting the surgery.

Secondary

MeasureTime frame
Number of Attempts for device placement through supraglottic airway device for endotracheal intubation among patients undergoing elective surgeryTimepoint: Immediately after successful insertion of supraglottic airway device, before starting the surgery.;Ease of endotracheal tube insertion through I-gel versus I-gel Plus as a conduit for endotracheal intubation among patients undergoing elective surgeryTimepoint: 10 minutes after successful insertion of supraglottic airway device, before starting the surgery.;Attempts for insertion of I-gel versus I-gel Plus in patients undergoing elective surgeryTimepoint: Immediately after successful insertion of supraglottic airway device, before starting the surgery.;Oropharyngeal leak pressure of I-gel versus I-gel Plus among patients undergoing elective surgeryTimepoint: 5 minutes after successful insertion of supraglottic airway device, before starting the surgery.;Leak fraction through I-gel versus I-gel Plus among patients undergoing elective surgeryTimepoint: 5 minutes after successful insertion of supraglottic airway device, before starting the surgery.;Peri-operative airway complications in both the groupsTimepoint: At the end of 24 hours of surgery

Countries

India

Contacts

Public ContactDr Rajesh Raman

King George Medical University, Lucknow

ramanrajesh83@gmail.com9451564339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026