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Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA Protector Cuff Pilot | Experimental |
| |
| LMA Supreme | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA Protector Cuff Pilot | Device | Assessing the clinical performance of LMA Protector Cuff Pilot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal leak pressure (OLP) | To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme | During induction of anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time to insertion | To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme | During induction of anaesthesia |
| Gastric tube insertion | To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia Medical Centre | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2018 | Jun 9, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2018 | Jun 9, 2019 | Prot_SAP_001.pdf |
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| LMA Supreme | Device | Assessing the clinical performance of LMA Supreme |
|
| After induction of anaesthesia |
| Laryngeal view | To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme | After induction of anaesthesia |
| Complications | To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme | 24 hours |