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

Not Applicable

Completed

• Conditions: Intubation Complication; Intubation; Difficult or Failed
• Interventions: Device: Ambu® AuraGain™; Procedure: neck extension

• Registration Number: NCT03408431
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-24
• Study Start: 2018-01-25
• Primary Completion: 2018-04-30
• Status Verified: 2018-05
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Ambu® AuraGain™	After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.
Group E	neck extension	After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.
Group C	Ambu® AuraGain™	After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Postoperative cough	24 hours after extubation	The incidence of postoperative cough
Postoperative hoarseness	24 hours after extubation	The incidence of postoperative hoarseness
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 sore throat	24 hours after extubation	The incidence of postoperative sore throat

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of