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A Study to Compare Two Devices (LMA Blockbuster and LMA Proseal) for Safe Breathing Support in Children Undergoing Surgery

Comparison of LMA Blockbuster and LMA Proseal for controlled ventilation in paediatric patients. - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/078880
Enrollment
70
Registered
2025-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: PCS-

Interventions

Intervention1: LMA BLOCKBUSTER: Laryngeal Mask Airway (LMA) Blockbuster, a supraglottic airway device designed for securing the airway during general anesthesia or controlled ventilation. The LMA Bloc

Sponsors

Postgraduate Institute of medical sciences Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with age group 5 years to 12 years with Mallampatti grade (MPG) 1 or 2 belonging to American society of Anaesthesiologists (ASA) I or II, undergoing elective surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: Difficult airway, BMI more than 95th percentile for the age, History of recent airway infection, Risk or history of Aspiration syndrome, Refusal to consent by parents/guardians will be excluded.

Design outcomes

Primary

MeasureTime frame
Comparison of Time of insertion, ease of insertion, number of attempts, Oropharyngeal leak pressure, Fiberoptic view scoring, Postoperative complications and hemodynamic monitoring after insertion of LMA Blockbuster and LMA Proseal.Timepoint: Baseline: Collect baseline measures (e.g., heart rate, oxygen saturation, blood pressure and end-tidal carbon dioxide). Immediately after insertion:- Time of insertion, Ease of insertion, number of attempts, Fiberoptic view scoring and Oropharyngeal leak pressure. Postoperative complications like blood stains on device, sore throat, hoarseness of voice.—

Secondary

MeasureTime frame
Number of attempts, Time of insertion, ease of insertion, fiberoptic view scoring, Oropharyngeal leak pressure, postoperative complications, hemodynamic monitoringTimepoint: Baseline: Collect baseline measures (e.g., heart rate, oxygen saturation, blood pressure & end-tidal carbon dioxide). Immediately after insertion:- Time of insertion, Ease of insertion, number of attempts, Fiberoptic view scoring & Oropharyngeal leak pressure. Postoperative complications like blood stains on device, sore throat, hoarseness of voice.—

Countries

India

Contacts

Public ContactDr Aanand

Department of Anaesthesia and critical care, Postgraduate Institute of medical sciences, Rohtak

drvandna4@gmail.com8750286684

Outcome results

None listed

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