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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A00741-54 | Other Identifier | ANSM |
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The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-SuprĆŖme devices will be ā¤ 5%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA-UNIQUEā¢ | Active Comparator |
| |
| LMA-SUPREMEā¢ | Active Comparator |
| |
| I-GELĀ® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of LMA-UNIQUE(TM) device | Procedure | LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pharyngolaryngeal postoperative pain of the three devices | Sore throat Y/N | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngolaryngeal postoperative pain between groups | Sore throat Y/N | 2 hours |
| Time taken to place device | From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joƫl L'Hermite, MD | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | NƮmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27755181 | Result | L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539. |
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| Insertion of LMA-SUPREME(TM) device | Procedure | LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation |
|
| Insertion of I-GEL(R) device | Procedure | I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation |
|
| End of surgery (maximum 2 hours) |
| Number of attempts needed to place device | End of surgery (maximum 2 hours) |
| Necessity of altering the size of the device | Y/N | End of surgery (maximum 2 hours) |
| Any patient movement during procedure | Y/N | End of surgery (maximum 2 hours) |
| Difficulty of insertion | 5-point scale: very easy-failure | End of surgery (maximum 2 hours) |
| Total leakage pressure of the devices | measured directly by the respirator | End of surgery (maximum 2 hours) |
| Ventilatory pressure of the devices | End of surgery (maximum 2 hours) |
| Device stability during surgery | Need to change the management system airways (orotracheal intubation or others) Y/N | End of surgery (maximum 2 hours) |
| Difficulty of device removal | 4-point scale: very easy-very difficult | End of surgery (maximum 2 hours) |