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Study on the Use of a Noval Supraglottic Airway Device in Children Undergoing ophthalmic Procedures

Performance Evaluation of a Novel Supraglottic Airway Device in Paediatric Ophthalmic Procedures: A Prospective Observational Study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092479
Enrollment
60
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere Health Condition 2: H351- Retinopathy of prematurity Health Condition 3: H260- Infantile and juvenile cataract Health Condition 4: H509- Unspecified strabismus

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Noval Supraglottic Device: Evaluation the clinical efficacy and performance of the novel supraglottic airway device (NSAD). Duration of s

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants from 1 day to 1 year old from patient weight 3 kg to 10 kg undergoing elective ophthalmic surgery

Exclusion criteria

Exclusion criteria: 1. Parental refusal 2. Syndromic child 3. Predicted difficult airway 4. Recent respiratory tract infection

Design outcomes

Primary

MeasureTime frame
To evaluate the clinical efficacy and performance of the novel supraglottic airway device (NSAD)Timepoint: Till 10 minutes from induction of anaesthesia—

Secondary

MeasureTime frame
first-attempt & over all insertion success rateTimepoint: Till 10 minutes from induction of anaesthesia;the time required for successful insertion.Timepoint: Till 10 minutes from induction of anaesthesia;the ease of NSAD insertionTimepoint: fTill 10 minutes from induction of anaesthesia;quality of ventilationTimepoint: 40 minutes from the time of anaesthesia induction;perioperative complicationsTimepoint: 40 minutes from the time of anaesthesia induction;surgeon satisfaction scoreTimepoint: At the end of the procedure—

Countries

India

Contacts

Public ContactDr Renu Sinha

All India Institute of Medical Sciences, New Delhi

renusinha@aiims.edu9810305156

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026