Comparison of oropharangeal seal pressure in supraglottic airway devices namely "AMBUAURA GAIN" versus "I GEL" in paediatric surgery patients under general anaesthesia

Comparison of oropharangeal seal pressure in supraglottic airway devices "AMBUAURA GAIN" Versus "I GEL" In paediatric surgery patients under general anaesthesia: A randomised interventional study at SMS medical college and attached group of hospitals, Jaipur during year 2019-2021

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026809

Enrollment

Registered

2020-07-27

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: O- Medical and Surgical

Interventions

Intervention1: I GEL: I GEL, a supraglottic airway device Intervention2: AMBUAURA GAIN: AMBUAURA GAIN, a supraglottic airway device Control Intervention1: I GEL: I GEL, a supraglottic airway device

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1 and 2 Weight between 10 to 30 kg Elective inguinal, urology procedure for which SADs are routinely used

Exclusion criteria

Exclusion criteria: Patient not willing to participate in study. Patient with active respiratory infection. Patient with difficult airway. emergency surgeries.

Design outcomes

Primary

Measure	Time frame
to determine difference in oropharangeal seal pressure in both groups.Timepoint: 30 min	—

Secondary

Measure	Time frame
to determine difference in % of cases with side effects in both groupsTimepoint: 0-5;to determine difference in mean grading of fiberoptic aperture visibility in both groupsTimepoint: 1-6;to determine difference in number of attempts for successful gastric tube insertion in both groupsTimepoint: 1-2;to determine the difference in mean time of insertion of deviceTimepoint: 30 s;to determine % of cases with successful insertion of deviceTimepoint: 1-2	—

Measure

Time frame

to determine difference in % of cases with side effects in both groupsTimepoint: 0-5;to determine difference in mean grading of fiberoptic aperture visibility in both groupsTimepoint: 1-6;to determine difference in number of attempts for successful gastric tube insertion in both groupsTimepoint: 1-2;to determine the difference in mean time of insertion of deviceTimepoint: 30 s;to determine % of cases with successful insertion of deviceTimepoint: 1-2

—

Countries

India

Contacts

Public ContactDr Deepika kumari

SMS medical college Jaipur

chatterjee.chandrashekhar@gmail.com

Outcome results

None listed

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