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

NCT ID: NCT03408431

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2018-05-01

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group E

After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.

Group Type: EXPERIMENTAL

Ambu® AuraGain™

Intervention Type: DEVICE

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.

neck extension

Intervention Type: PROCEDURE

Patients' neck will be maximally extended (\~60°) during blind intubation.

Group C

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

Group Type: ACTIVE_COMPARATOR

Ambu® AuraGain™

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

neck extension

Patients' neck will be maximally extended (\~60°) during blind intubation.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Tae Kim, PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30919236 (View on PubMed)

Other Identifiers

H-1709-123-890

Identifier Type: -

Identifier Source: org_study_id