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Study of two devices for management of airway during anaesthesia in children

A randomised controlled study to compare oropharyngeal leak pressure in two different second generation supraglottic airway devices in children under general anaesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022970
Enrollment
80
Registered
2020-01-27
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: A00-B99- Certain infectious and parasitic diseases Health Condition 2: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 3: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Health Condition 4: H60-H95- Diseases of the ear and mastoid process Health Condition 5: H00-H59- Diseases of the eye and adnexa Health Condition 6: N00-N99- Diseases of the genitourinary system Health

Interventions

Intervention1: LMA supreme: device will be inserted and adequacy of ventilation and oropharyngeal leak pressure will be measured Control Intervention1: I gel: device will be inserted and adequacy of v

Sponsors

Llady hardinge medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Either sex 2. less than or equal to 10kg of body weight 3. ASA grade I & II 4. Adequate nutritional status ( -2 to +2 z scores for weight for age)

Exclusion criteria

Exclusion criteria: 1. Congenital airway abnormality 2. Anticipated difficult airway 3. Upper respiratory infections 4. Risk of aspiration (gastrointestinal obstruction, pyloric stenosis)

Design outcomes

Primary

MeasureTime frame
Mean ± SD of Oropharyngeal leak pressure (OLP) in i-gel and LMA supreme.Timepoint: after successful insertion of device—

Secondary

MeasureTime frame
Fiberoptic view of larynx grading in both groupsTimepoint: After successful insertion of device;Mean ± SD of insertion time (seconds) in both groupsTimepoint: After successful insertion of device;Proportion of number of insertion attempts in both groupsTimepoint: After successful insertion of device;Proportion of number of manipulations in both groupsTimepoint: After successful insertion of device;Proportion of patients in whom device could be inserted easily in both groupsTimepoint: After successful insertion of device;Proportion of perioperative complications in both groupsTimepoint: After successful removal of device;Proportion of successful insertion at 1st attempt in both groupsTimepoint: After successful insertion of device—

Countries

India

Contacts

Public ContactDr Sunil kumar sinha

Lady hardinge medical college

sunilsinha248@gmail.com9868493597

Outcome results

None listed

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