To compare the efficacy of 2 single use airway devices with a reusable airway device to see how well they support breathing in children during surgery under general anaesthesia.

Comparison of efficacy of two single use supraglottic devices with a reusable supraglottic device for ventilation in paediatric patients undergoing elective surgery under general anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094315

Enrollment

156

Registered

2025-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: BlockBuster LMA: BlockBuster Laryngeal Mask Airway (LMA) of appropriate size, as per manufacturer?s recommendation, will be inserted in paediatric patients undergoing elective surgery u

Eligibility

Inclusion criteria

Inclusion criteria: This study will be conducted in children weighing 10 - 30 kg, fulfilling the criteria of American Society of Anaesthesiologists (ASA) Physical Status 1 and 2, undergoing elective surgery under general anaesthesia with controlled ventilation.

Exclusion criteria

Exclusion criteria: 1. Patients with an anticipated difficult airway. 2. Patient with high risk of aspiration.

Design outcomes

Primary

Measure	Time frame
Oropharyngeal seal pressure of the device will be measured.Timepoint: Oropharyngeal seal pressure of the device will be measured at 5 minutes and 30 minutes after insertion of device.	—

Secondary

Measure	Time frame
Number of attempts taken for successful insertion of the device.Timepoint: This will be noted after the successful insertion of the device.;Time taken for achieving effective ventilation.Timepoint: It will be noted from, holding the supraglottic device at the teeth for insertion, to obtaining the first square wave capnograph tracing, confirming effective ventilation.;Anatomical alignment of the device to glottic opening by Brimacombe score.Timepoint: It will be measured after the insertion of the device.;The ease of insertion of the device and the gastric catheter will be noted.Timepoint: It will be noted after insertion of the device and the gastric catheter.	—

Measure

Time frame

Number of attempts taken for successful insertion of the device.Timepoint: This will be noted after the successful insertion of the device.;Time taken for achieving effective ventilation.Timepoint: It will be noted from, holding the supraglottic device at the teeth for insertion, to obtaining the first square wave capnograph tracing, confirming effective ventilation.;Anatomical alignment of the device to glottic opening by Brimacombe score.Timepoint: It will be measured after the insertion of the device.;The ease of insertion of the device and the gastric catheter will be noted.Timepoint: It will be noted after insertion of the device and the gastric catheter.

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Countries

India

Contacts

Public ContactDr Nidhi Agrawal

VMMC and Safdarjung Hospital

nidhi.agrawal1970@gmail.com9811030408

Outcome results

None listed

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