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

Laryngeal Mask Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478983
• Other study ID #: 995.7
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: January 2022
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Mask Airway

Intervention

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.
• 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.

Locations

Country	Name	City	State
Malaysia	Faculty of Medicine, University of Malaya	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressure	The measurement of oropharyngeal airway pressure when airway leak occurred	intraoperative
Secondary	Insertion success rate	The number of attempts for successful placement of the supraglottic airway is recorded.	intraoperative
Secondary	Fibreoptic glottis view	Fibreoptic glottis view will be recorded according to a grading system	intraoperative
Secondary	Intraoperative complications	Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded	intraoperative
Secondary	Time to insertion	Time from picking up the supraglottic airway device to the first detection of capnography square wave	intraoperative