An interventional study of LMA Supreme and LMA Proseal in Laryngeal Mask Airway, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 2 Months to 2 Years. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
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.
University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 arm will receive LMA supreme for airway management
Device: LMA Supreme
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.
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.
Oropharyngeal leak pressure
The measurement of oropharyngeal airway pressure when airway leak occurred
Time frame: intraoperative
Insertion success rate
The number of attempts for successful placement of the supraglottic airway is recorded.
Time frame: intraoperative
Fibreoptic glottis view
Fibreoptic glottis view will be recorded according to a grading system
Time frame: intraoperative
Intraoperative complications
Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded
Time frame: intraoperative
Time to insertion
Time from picking up the supraglottic airway device to the first detection of capnography square wave
Time frame: intraoperative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Malaya