Skip to main content
OpenTrials
Completed

NCT Number: NCT03408431

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

neck extension

Procedure

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

Primary outcomes

  1. Success rate in first attempt

    Time frame: In a first attempt for blind intubation, an average of 30 seconds

    Successful blind intubation in a first attempt

Secondary outcomes

  1. Overall success rate

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

    Successful blind intubation within a maximum of two attempts

  2. Time for blind intubation

    Time frame: 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

  3. Postoperative hoarseness

    Time frame: 24 hours after extubation

    The incidence of postoperative hoarseness

  4. Postoperative cough

    Time frame: 24 hours after extubation

    The incidence of postoperative cough

  5. Postoperative sore throat

    Time frame: 24 hours after extubation

    The incidence of postoperative sore throat

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.