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

A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Mask Airway
• Intervention / Treatment: Device: LMA Supreme; Device: LMA Proseal

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
      • Faculty of Medicine, University of Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LMA Supreme; 1 arm will receive LMA supreme for airway management	Device: LMA Supreme; The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
Active Comparator: LMA Proseal; 1 arm will receive LMA Proseal for airway management	Device: LMA Proseal; The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure	The measurement of oropharyngeal airway pressure when airway leak occurred	intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Sook Hui Chaw, M.Med, University of Malaya

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 7, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 995.7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No