A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
NCT ID: NCT02478983
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LMA Supreme
1 arm will receive LMA supreme for airway management
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
1 arm will receive LMA Proseal for airway management
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Months
2 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Chaw Sook Hui
Dr.
Principal Investigators
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Sook Hui Chaw, M.Med
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Locations
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Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Other Identifiers
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995.7
Identifier Type: -
Identifier Source: org_study_id
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