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In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the success rate of blind intubation through laryngeal mask.
Participants undergoing general anesthesia will be randomly assigned to group E (with neck extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if blind intubation succeed. Blind intubation will be performed with a maximum of two attempts. If all attempts failed, the laryngeal mask will be removed and the tube will be intubated using a direct laryngoscopy.
The primary outcome of this study is the success rate of blind intubation within a first attempt. Secondary outcomes included overall success rate of blind intubation within a maximum of two attempts, time for blind intubation, the incidence of postoperative hoarseness, cough, and sore throat, and any obvious complications related to airway management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group E | Experimental | After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning. |
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| Group C | Active Comparator | After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu® AuraGain™ | Device | Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask under each position according to the assigned group. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate in first attempt | Successful blind intubation in a first attempt | In a first attempt for blind intubation, an average of 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Overall success rate | Successful blind intubation within a maximum of two attempts | In a maximum of two attempts for blind intubation, an average of 60 seconds |
| Time for blind intubation | Time between insertion of an endotracheal tube within the laryngeal mask and detection of end-tidal CO2 from the tube |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30919236 | Derived | Yoo S, Park SK, Kim WH, Hur M, Bahk JH, Lim YJ, Kim JT. The effect of neck extension on success rate of blind intubation through Ambu(R) AuraGain laryngeal mask: a randomized clinical trial. Can J Anaesth. 2019 Jun;66(6):639-647. doi: 10.1007/s12630-019-01353-4. Epub 2019 Mar 27. |
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Randomized controlled trial
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| neck extension | Procedure | Patients' neck will be maximally extended (~60°) during blind intubation. |
|
| In a maximum of two attempts for blind intubation, an average of 60 seconds |
| Postoperative hoarseness | The incidence of postoperative hoarseness | 24 hours after extubation |
| Postoperative cough | The incidence of postoperative cough | 24 hours after extubation |
| Postoperative sore throat | The incidence of postoperative sore throat | 24 hours after extubation |