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Comparing the working characteristic of an anaesthesia delivery device called I-gel when it is placed blindly using the clinicians fingers compared to when it is placed using two different types of devices called videolaryngoscopes

Comparative evaluation of performance characteristics of conventional digital insertion of I-gel versus I-gel inserted using two different videolaryngoscopes in infants. A clinical, comparative randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111242
Enrollment
105
Registered
2026-05-27
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: Blind digital Insertion Group : Blind digital Insertion The patient who will be randomly allocated to this group will have the I gel inserted in their airway blindly guided by the clin

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Infants (0-1 year) 2)Either gender 3)ASA I and II patients 4)Elective Surgery

Exclusion criteria

Exclusion criteria: 1)Refusal to participate in the study 2) Features of/anticipated/history of difficult airway 3) Mass in pharyngeal/laryngeal cavity 4) Prematurity 5) Increased intracranial pressure or cervical spine diseases 6) Significant systemic diseases (cardiovascular/ endocrine diseases) 7) presence of risk factors for gastric aspiration 8) Active respiratory tract infection 9) Emergency surgery 10) Syndromic babies

Design outcomes

Primary

MeasureTime frame
Comparison of incidence of malposition as observed fibreoptically when I-Gel is inserted digitally in a blind fashion versus I-Gel inserted using two different videolaryngoscopes.Timepoint: Ten Minutes after the I-gel inserion and fixation by inserting a paediatric fibreoptic bronchoscope by an independent observer—

Secondary

MeasureTime frame
First attempt success ratesTimepoint: Immediately after insertion of I-gel;Number of insertion attemptsTimepoint: Immediately after insertion of I-gel;Time taken for insertion of I-gelTimepoint: Immediately after insertion of I -gel;Oropharyngeal Leak Pressure comparisonTimepoint: Five minutes after I-gel insertion and fixation by the attending anaesthesiologist;Haemodynamic parameters(Heart rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation.Timepoint: Immediately after insertion, after one minute, after three minutes,after five minutes and after ten minutes of insertion;Any side effects like injury, hoarse cry, desaturation, nausea or vomitingTimepoint: Upto sixty minutes after removal of I-gel—

Countries

India

Contacts

Public ContactRudrashish Haldar

Sanjay Gandhi Post Graduate Institute of Medical Sciences

dr.anurag.sgpgi@gmail.com05222494497

Outcome results

None listed

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