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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408431
• Other study ID #: H-1709-123-890
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative hoarseness	The incidence of postoperative hoarseness	24 hours after extubation
Secondary	Postoperative cough	The incidence of postoperative cough	24 hours after extubation
Secondary	Postoperative sore throat	The incidence of postoperative sore throat	24 hours after extubation