A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg

Not Applicable

Completed

• Conditions: Laryngeal Mask Airway
• Interventions: Device: LMA Supreme; Device: LMA Proseal

• Registration Number: NCT02478983
• Lead Sponsor: University of Malaya

Brief Summary

The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing \<10kg.

Detailed Description

This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-06-07
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-23
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Weight of < 10kg
• ASA (American Society of Anesthesiologists) I-II
• Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
• Informed consent obtained from parents.

Exclusion Criteria

• ASA III-IV and emergency surgery
• Neonates and ex-premature babies with post conceptual age <55 weeks.
• Infants with history of difficult airway.
• Infants with features of difficult intubation.
• Active upper respiratory tract infection
• Infants with pulmonary disease
• Infants with history of gastroesophageal reflux disease
• Infants with risks of regurgitation and aspiration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Supreme	LMA Supreme	1 arm will receive LMA supreme for airway management
LMA Proseal	LMA Proseal	1 arm will receive LMA Proseal for airway management

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	intraoperative	The measurement of oropharyngeal airway pressure when airway leak occurred

Secondary Outcome Measures

Name	Time	Method
Fibreoptic glottis view	intraoperative	Fibreoptic glottis view will be recorded according to a grading system
Time to insertion	intraoperative	Time from picking up the supraglottic airway device to the first detection of capnography square wave
Insertion success rate	intraoperative	The number of attempts for successful placement of the supraglottic airway is recorded.
Intraoperative complications	intraoperative	Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded

Trial Locations

Locations (1)

Faculty of Medicine, University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia