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Comparison of two airway devices (Ambu AuraGain with LMA ProSeal) for anaesthesia in Children.

Comparison of Ambu AuraGain with LMA ProSeal in Children under Controlled Ventilation: A Randomised Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007175
Enrollment
94
Registered
2016-08-11
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: Ambu AuraGain: AuraGain is a second generation single use supraglottic device promising high levels of safety and efficacy with higher oropharyngeal sealing pressure and better first at

Sponsors

Jawaharlal Institute of Postgraduation Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children below 18years weighing between 5-30 kilograms. 2.Children undergoing inguino-scrotal or orthopedic procedure in supine position. 3.American Society of Anaesthesiologists classification 1 and 2.

Exclusion criteria

Exclusion criteria: 1.Anticipated difficult airway. 2.Any pathology of the neck, upper respiratory tract or upper alimentary tract. 3.Emergent surgery. 4.Active gastrointestinal reflux. 5.Active respiratory infection or lung disease.

Design outcomes

Primary

MeasureTime frame
To assess and compare the oropharyngeal seal pressure between Ambu AuraGain and ProSeal LMA in children.Timepoint: The minimum expected difference in the mean oropharyngeal leak pressure was 5 cm of H2O with a standard deviation of 7.5 cm of H2O.

Secondary

MeasureTime frame
To assess and compare the attempts taken for successful placement between Ambu AuraGain and ProSeal LMA in children.Timepoint: 1 to 3;To assess and compare the ease of insertion between Ambu AuraGain and ProSeal LMA in children.Timepoint: 1-No resistance, 2-mild resistance, 3-moderate resistance, 4-unable to pass device.;To assess and compare the ease of insertion of gastric tube between Ambu AuraGain and ProSeal LMA in children. Timepoint: 1- Easy, 2- difficult, 3- unable to pass;To assess and compare the fibreoptic view of larynx between Ambu AuraGain and ProSeal LMA in children.Timepoint: Brimacombe score: 1-vocal cords not seen, 2- vocal cords plus anterior epiglottis seen, 3- vocal cords plus posterior epiglottis seen, 4 ââ?¬â?? only vocal cords visible.;To assess and compare the incidence of complications in postoperative period between Ambu AuraGain and ProSeal LMA in children.Timepoint: Bleeding, laryngospasm, hoarseness, sore throat and cough.;To assess and compare the time taken for successful placement between Ambu AuraGain and ProSeal LMA in children. Timepoint: Duration in Seconds

Countries

India

Contacts

Public ContactDr Reesha Joshi

Jawaharlal Institute of Postgraduate Medical Education and Research

priyaab8@gmail.com8903477132

Outcome results

None listed

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