Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial

Conditions
-----------------
Intubation; Difficult or Failed, Intubation Complication

Intervention / Treatment
-----------------
* Device: Ambu® AuraGain™
* Procedure: neck extension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing general anesthesia with endotracheal intubation Exclusion Criteria: Emergency operation History of esophageal, oropharyngeal, or laryngeal disease History of cervical spine surgery Insufficient NPO time Loosening teeth Mouth opening less than 2cm

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E<br>After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning. | Device: Ambu® AuraGain™<br>* 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.<br>Procedure: neck extension<br>* Patients' neck will be maximally extended ( 60°) during blind intubation.<br>|
| Active Comparator: Group C<br>After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position. | Device: Ambu® AuraGain™<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |