NCT03408431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

January 10, 2018

Last Update Submit

May 1, 2018

Conditions

Intubation; Difficult or FailedIntubation Complication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Overall success rate

    In a maximum of two attempts for blind intubation, an average of 60 seconds

  • Time for blind intubation

    In a maximum of two attempts for blind intubation, an average of 60 seconds

  • Postoperative hoarseness

    24 hours after extubation

  • Postoperative cough

    24 hours after extubation

  • Postoperative sore throat

    24 hours after extubation

Study Arms (2)

Group E

EXPERIMENTAL

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

Device: Ambu® AuraGain™Procedure: neck extension

Group C

ACTIVE COMPARATOR

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™

Interventions

Ambu® AuraGain™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.

Group CGroup E
neck extensionPROCEDURE

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

Group E

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing general anesthesia with endotracheal intubation

You may not qualify if:

  • Emergency operation
  • History of esophageal, oropharyngeal, or laryngeal disease
  • History of cervical spine surgery
  • Insufficient NPO time
  • Loosening teeth
  • Mouth opening less than 2cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30919236DERIVED

Study Officials

  • Jin-Tae Kim, PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 24, 2018

Study Start

January 25, 2018

Primary Completion

April 30, 2018

Study Completion

May 1, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

KR(1)