Comparison of two airway devices to provide ventilation in children undergoing anaesthesia

Comparison of Ambu aura gain and Block buster laryngeal mask for controlled ventilation in children undergoing general anaesthesia: A prospective randomised study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031946

Enrollment

Registered

2021-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Block buster laryngeal mask group: Block buster laryngeal mask will be used maintain airway and to provide anaesthesia. Maximum of 2 attempts. Duration till the end of surgery. Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of age 6 months-12 yrs undergoing elective surgery under general anaesthesia 2. Weight 5-30 kgs 3. ASA 1 and 2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare oropharyngeal leak pressure of two devicesTimepoint: Once after insertion of the device	—

Secondary

Measure	Time frame
1. First insertion success rate of LM 2. Overall insertion success rate of LM 3. Gastric access tube insertion success rate 4. Time for successful insertion of LM 5. Ease of LM insertion 6. Glottic view assessed by fiberoptic bronchoscope Timepoint: Once after insertion of the device;7. Amount of blood stain over posterior surface of LMA cuff 8. Complications (Regurgitation, laryngospasm, dysphonia, dysphagia)Timepoint: Once after removal of device in post anaesthesia care unit	—

Measure

Time frame

1. First insertion success rate of LM 2. Overall insertion success rate of LM 3. Gastric access tube insertion success rate 4. Time for successful insertion of LM 5. Ease of LM insertion 6. Glottic view assessed by fiberoptic bronchoscope Timepoint: Once after insertion of the device;7. Amount of blood stain over posterior surface of LMA cuff 8. Complications (Regurgitation, laryngospasm, dysphonia, dysphagia)Timepoint: Once after removal of device in post anaesthesia care unit

—

Countries

India

Contacts

Public ContactKanil Ranjith Kumar

All India Institute of Medical Sciences, New Delhi.

kanil.aiims@gmail.com8800314575

Outcome results

None listed

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