Comparison of the ear size-based method with the standard weight-based method of selection of Proseal Laryngeal Mask Airway (PLMA), a tool used to provide anaesthesia, among children undergoing surgery.

A randomized control trial to compare the auricle size-based method for Proseal Laryngeal Mask Airway (PLMA) selection with the standard weight-based method among paediatric patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015682

Enrollment

Registered

2018-09-11

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

None listed

Interventions

Intervention1: Pro Seal LMA based on Auricle size: Auricle size to determine Pro Seal LMA Size Control Intervention1: Standard weight based method for Proseal LMA size: Standard weight based method fo

Eligibility

Inclusion criteria

Inclusion criteria: 1.Paediatric patients undergoing elective surgical procedures of short duration ( 2. Age: 6 months to 18 years 3. American Society of Anesthesiologists Physical Status I and II 4. Parents of children willing to comply with informed written consent

Exclusion criteria

Exclusion criteria: 1. Children requiring tracheal intubation 2. Expected duration of surgery greater than 2h 3. History of any oropharyngeal lesion except tonsillar hypertrophy. 4. Emergency surgeries and patients with history of hiatus hernia. 5. Patients with history of obstructive sleep apnoea, obesity 6. Recent history of respiratory tract infection. 7. Children requiring rapid sequence induction. 8. Children with unstable cervical spine or limited neck mobility. 9. Children with cleft palate of any degree. 10. Anticipated difficult airway. 11. Complete upper airway obstruction. 12. Suspected or known abnormalities of the airway. 13. Patients with musculoskeletal disorders.

Design outcomes

Primary

Measure	Time frame
To compare the auricle size-based method with the weight-based method of selection of PLMA in successful insertion among paediatric patients.Timepoint: Baseline and post insertion of PLMA	—

Secondary

Measure	Time frame
To assess the rate of successful first attempts of PLMA insertion with the auricle size-based method compared to the weight-based method among paediatric patientsTimepoint: post insertion of PLMA	—

Countries

India

Contacts

Public ContactDr Nisha Sara M Jacob

Kasturba Medical College, Manipal

nishasara@gmail.com9500574751

Outcome results