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To compare two laryngeal airway devices IGel and Supreme Laryngeal mask airway with respect to their insertion characteristics, seal presure and quality of airway maintenance in children for minor surgeries.

Insertion characteristics, sealing pressure and quality of airway maintenance with igel versus LMA supreme in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/006057
Enrollment
60
Registered
2015-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Insertion characteristics, sealing pressure and quality of airway maintenance with i-gel versus LMA supreme in children

Interventions

Intervention1: i-gel: i-gel is a second generation supraglottic airway device. It has a soft gel like non inflatable cuff designed to provide anatomical fit over the laryngeal inlet.The makers claim t

Sponsors

LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL SION
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. ASA-I and II 2. Either sex 3. Age group 3 months to 8 years

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Age group 3 months and 8 years 2. ASA III and above 3. Non starved patients 4. Patients with increased risk of regurgitation-e.g. hiatus hernia, intestinal obstruction, sepsis 5. History of extrinsic or intrinsic airway obstruction due to trauma/mass/caustic substance ingestion 6. Potential difficult airways 7. Upper gastrointestinal tract surgeries in the past 8. Patients with esophageal pathology/Gastroesophageal reflux disease 9. Head and neck surgery 10. Upper respiratory tract infection like fever, cough, rhinorrhoea, croup, sore throat 11. Patients with poor lung compliance 12. Bleeding/clotting abnormality

Design outcomes

Primary

MeasureTime frame
Comparison of clinical performance of i-gel with LMA-Supreme in children undergoing elective surgery under general anaesthesia. Comparison is with respect to: 1. Ease of insertion 2. Number of attempts for insertion 3. Seal pressure/Airway leak pressure 4. Quality of airway maintenance during anaesthesiaTimepoint: 1. Ease of insertion will be noted one time immediately after insertion of the device 2. Number of attempts for insertion will be noted one time immediately after failure of previous attempt/attempts. 3. Seal pressure/Airway leak pressure will be noted one time immediately after insertion of the device. 4. Quality of airway maintenance during anaesthesia every 5 minutes till procedure is completed

Secondary

MeasureTime frame
1.Airway interventions required for insertion 2.Incidence of gastric insufflation 3.Ease of insertion of gastric tube 4.Number of manipulations required to maintain patent airway 5.ComplicationsTimepoint: 1.Airway interventions required for insertion noted one time after insertion of the device 2.Incidence of gastric insufflation noted one time after insertion of the device 3.Ease of insertion of gastric tube noted one time after insertion of the device 4.Number of manipulations required to maintain patent airway will be noted every 5 minutes during the procedure. 5. Complications will be monitored during procedure every 5 minutes and hourly till discharge of patients.

Countries

India

Contacts

Public ContactDr Anila D Malde

Lokamanya Tilak Municipal Medical College

dradmalde@yahoo.com91-9821085730

Outcome results

None listed

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