Trials / Completed
CompletedNCT02478983
A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Malaya · Academic / Other
- Sex
- All
- Age
- 2 Months – 2 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2015-06-23
- Last updated
- 2022-01-28
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT02478983. Inclusion in this directory is not an endorsement.