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Comparative efficacy and safety of two supraglottic airway devices during general anaesthesia in children

Comparative efficacy and safety of I-gel supraglottic airway and self pressurizing Air-Q intubating laryngeal airway during general anaesthesia in infants: A prospective randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014473
Enrollment
100
Registered
2018-06-08
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- ASA I and II children below 1 year of age posted for ophthalmic surgery of 20 min-2 hr duration

Interventions

Intervention1: Air-Qsp: The air-Qsp, which is a new self-pressurizing masked laryngeal airway has a unique cuff design. The mask cuff of Air-Qsp inflates appropriately upon inhalation with positive pr

Sponsors

Department of Anaesthesiology Pain medicine and Critical care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants below 1yr. of age Posted for Only elective ophthalmic surgery ASA I & II patients Duration of surgery (20 mins-2 hrs)

Exclusion criteria

Exclusion criteria: All patients above 1 year of age Not willing to consent (Consent taken from parents) Infants with any-airway anomalies, active URTI, known difficult airway, lung disease requiring high PEEP

Design outcomes

Primary

MeasureTime frame
Oropharyngeal Leak Pressure (in cm H2O)Timepoint: Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery—

Secondary

MeasureTime frame
1. First insertion success rate 2. Time to insert (in seconds) 3. No. of attempts for successful insertion 4. Fibreoptic bronchoscopic view of glottis through the supraglottic airway device 5. Post op. Complications (repeated episodes of cough, laryngospasm, desaturation) Timepoint: Time to Insert- Time between picking up the device and chest rise with PPV Fibre-optic bronchoscopic (FOB) view-breathing system will be briefly disconnected after insertion and confirmation of device and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view. Post-operative Complications- Blood stain on device (oropharyngeal trauma), repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted after removal of device at the end of surgery—

Countries

India

Contacts

Public ContactDr Neha Pangasa

All India Institute Of Mediical Sciences New Delhi

nehapangasa@gmail.com9810383313

Outcome results

None listed

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