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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02478983 |
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Date of registration:
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07/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
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Scientific title:
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A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02478983 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Sook Hui Chaw, M.Med |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Malaya |
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Key inclusion & exclusion criteria
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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.
Age minimum:
2 Months
Age maximum:
2 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Laryngeal Mask Airway
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Intervention(s)
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Device: LMA Supreme
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Device: LMA Proseal
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Primary Outcome(s)
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Oropharyngeal leak pressure
[Time Frame: intraoperative]
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Secondary Outcome(s)
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Insertion success rate
[Time Frame: intraoperative]
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Fibreoptic glottis view
[Time Frame: intraoperative]
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Intraoperative complications
[Time Frame: intraoperative]
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Time to insertion
[Time Frame: intraoperative]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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