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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Intubation; Difficult or Failed
• Intervention / Treatment: Device: Ambu® AuraGain™; Procedure: neck extension

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group E; After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.	Device: Ambu® 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.; Procedure: neck extension; Patients' neck will be maximally extended (~60°) during blind intubation.
ACTIVE_COMPARATOR: Group C; 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™; 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.

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, PhD., Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H-1709-123-890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No