Clinical trial NCT03408431: Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™
Official title: Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Intubation Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Success rate in first attempt
timeFrame: In a first attempt for blind intubation, an average of 30 seconds
Secondary outcomes:
measure: Overall success rate
timeFrame: In a maximum of two attempts for blind intubation, an average of 60 seconds
measure: Time for blind intubation
timeFrame: In a maximum of two attempts for blind intubation, an average of 60 seconds
measure: Postoperative hoarseness
timeFrame: 24 hours after extubation
measure: Postoperative cough
timeFrame: 24 hours after extubation
measure: Postoperative sore throat
timeFrame: 24 hours after extubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.