A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 7, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJanuary 28, 2022
January 1, 2022
1.9 years
June 7, 2015
January 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Oropharyngeal leak pressure
The measurement of oropharyngeal airway pressure when airway leak occurred
intraoperative
Secondary Outcomes (4)
Insertion success rate
intraoperative
Fibreoptic glottis view
intraoperative
Intraoperative complications
intraoperative
Time to insertion
intraoperative
Study Arms (2)
LMA Supreme
EXPERIMENTAL1 arm will receive LMA supreme for airway management
LMA Proseal
ACTIVE COMPARATOR1 arm will receive LMA Proseal for airway management
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603, Malaysia
Study Officials
- PRINCIPAL INVESTIGATOR
Sook Hui Chaw, M.Med
University of Malaya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 7, 2015
First Posted
June 23, 2015
Study Start
June 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
January 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share