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Comparison of Ambu® Aura40TM laryngeal mask and BlockBuster™ laryngeal mask airway in infants undergoing eye surgery

Clinical performance of Ambu® Aura40TM laryngeal mask versus BlockBuster™ laryngeal mask airway for controlled ventilation in infants for ophthalmic procedures under General Anaesthesia: A Randomized Crossover Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060044
Enrollment
35
Registered
2023-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: BlockBusterTM Laryngeal Mask Airway (LMA) (Tuoren Medical Instrument Co., Ltd., Changyuan City, China): It is a new second-generation silicon based reusable Supraglottic Airway (SGA) wh

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a)Age: less than 12 months b)ASA PS: 1 or 2 c)Infants with bilateral eye disease requiring surgery for one eye followed by surgery of other eye after 3 days during the same hospital stay

Exclusion criteria

Exclusion criteria: a)Parental refusal b)ASA PS 3 or above c)Difficult airway d)Infants who had URI in the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
To compare the Oropharyngeal Leak Pressure of Ambu Aura40 LM with BlockBuster LMA in Infants.Timepoint: 0 minutes & 10 minutes after successful insertion of supraglottic airway device

Secondary

MeasureTime frame
Complications including laryngospasm, bronchospasm, desaturationTimepoint: From device insertion to device removal;Presence of blood stain over the posterior surface of the SGA cuffTimepoint: At time of removal of device;To compare ease of SGA insertionTimepoint: At time of insertion of device;To compare first attempt success rateTimepoint: At time of insertion of device;To compare glottic view assessed by fiberoptic bronchoscopeTimepoint: After airway device insertion;To compare overall insertion success rateTimepoint: At time of insertion of device;To compare time for successful insertion of deviceTimepoint: From removal of the face mask to device insertion & the reappearance of EtCO2 with the first manual breath.

Countries

India

Contacts

Public ContactAnirudh Kansal

All India Institute of Medical Sciences, Delhi

renusinha@aiims.edu9810305156

Outcome results

None listed

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