Intubation Complication, Intubation; Difficult or Failed
Conditions
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.
Interventions
DEVICEAmbu® AuraGain™
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.
PROCEDUREneck extension
Patients' neck will be maximally extended (\ 60°) during blind intubation.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate in first attempt | In a first attempt for blind intubation, an average of 30 seconds | Successful blind intubation in a first attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall success rate | In a maximum of two attempts for blind intubation, an average of 60 seconds | Successful blind intubation within a maximum of two attempts |
| Time for blind intubation | In a maximum of two attempts for blind intubation, an average of 60 seconds | Time between insertion of an endotracheal tube within the laryngeal mask and detection of end-tidal CO2 from the tube |
| Postoperative hoarseness | 24 hours after extubation | The incidence of postoperative hoarseness |
| Postoperative cough | 24 hours after extubation | The incidence of postoperative cough |
| Postoperative sore throat | 24 hours after extubation | The incidence of postoperative sore throat |
Countries
South Korea
Outcome results
None listed