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evaluation of a new method of insertion of ProSeal LMA vis-a-vis the standard technique

Comparative Evaluation of ProSeal Laryngeal Mask Airway Insertion with Airway versus Standard-of-Care Introducer-aided Technique: A Randomised Control Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007058
Enrollment
100
Registered
2016-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- children weighing upto 20kg, undergoing elective, daycare surgeries under general anaesthesia and requiring use of the ProSeal LMA for airway management

Interventions

Intervention1: Airway Technique of ProSeal LMA insertion: a newer technique of insertion of the ProSeal LMA being evaluated Control Intervention1: Introducer aided insertion of the ProSeal LMA: The

Sponsors

Sir Ganga Ram Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II weighing upto 20 kg scheduled to undergo elective, daycare surgery requiring general anaesthesia using the ProSeal LMA for airway management

Exclusion criteria

Exclusion criteria: anticipated difficult airway ASA physical status more than II asthma or reactive airway disease not fulfilling fasting guidelines undergoing head and neck surgery

Design outcomes

Primary

MeasureTime frame
first attempt success rateTimepoint: at the end of insertion (after confirmation of adequate function)

Secondary

MeasureTime frame
complications (rate and event if any)Timepoint: at end of surgery;ease of insertionTimepoint: at the end of insertion (after confirmation of adequate function);fibrescope findingTimepoint: at the end of insertion (after confirmation of adequate function);insertion timeTimepoint: at the end of insertion (after confirmation of adequate function);number of attemptsTimepoint: at the end of insertion (after confirmation of adequate function);oropharyngeal sealing pressure (OSP)Timepoint: at the end of insertion (after confirmation of adequate function);overall success rateTimepoint: at the end of insertion (after confirmation of adequate function)

Countries

India

Contacts

Public ContactDr Deepanjali Pant

Sir Ganga Ram Hospital

deepanjalipant@gmail.com09818271871

Outcome results

None listed

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