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A study comparing LMA Supreme with LMA Unique in children to find out which is better for surgical cases.

A Randomized Trial Comparing The Laryngeal Mask Airway Supremeâ?¢ With The Laryngeal Mask Airway Uniqueâ?¢ In Anaesthetised And Paralysed Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011136
Enrollment
42
Registered
2018-01-04
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- 1. Children undergoing elective day surgeries where a size 1.5,2 and 2.5 of LMA Unique will normally be used for airway maintenance. 2. ASA grade I and II. 3. Age between 6 months and 8 years Health Condition 2: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: LMA Supreme size 1.5 , 2 and 2.5: Laryngeal mask airways (LMA) are supraglottic airway devices (SGA) which have become a standard fixture in airway management, filling the niche between

Sponsors

Armed Forces Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: STUDY POPULATION Children undergoing elective day surgeries where a size 1.5,2 and 2.5 of LMA Unique will normally be used for airway maintenance will be enrolled in the study CRITERIA FOR SELECTION OF SUBJECTS 1. ASA grade I and II. 2. Age between 6 months and 8 years

Exclusion criteria

Exclusion criteria: CRITERIA FOR EXCLUSION 1. Patients with acute respiratory illness (cough, fever and rhinorrhea) on the day of anaesthesia 2. Anticipated difficult airway

Design outcomes

Primary

MeasureTime frame
1. Primary outcome: Airway leak pressure. 2. Secondary outcome: a. The ease of insertion b. Insertion success rate c. Ease of gastric tube placement (in LMA Supreme) d. Quality of airway patency e. Complications Timepoint: Airway leak pressure will me measured after the successful insertion of the device

Secondary

MeasureTime frame
2. Secondary outcome: a. The ease of insertion b. Insertion success rate c. Ease of gastric tube placement (in LMA Supreme) d. Quality of airway patency e. Complications Timepoint: Time of successful insertion is frm th removal of face mask to the first capnography upstroke

Countries

India

Contacts

Public ContactVipin Sukumaran

Army hospital research and referral, New Delhi

amitduadua@yahoo.com7767834036

Outcome results

None listed

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