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NCT Number: NCT03908411

The Effect of Paratracheal Pressure on the Glottic View

Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.

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Key information

Conditions

Paratracheal Pressure Airway Management Cricoid Pressure Sellick's Maneuver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMG - SNU Boramae Medical Center, Seoul, South Korea

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About this study

Primary outcome:

-Cormack-Lehane grade

Secondary outcome:

  • POGO score before and after application of each intervention
  • Difficulties of mask ventilation after application of each intervention
  • Inspiratory pressure and tidal volume during manual mask ventilation
  • Rates of worsening of the glottic view after intervention
  • The difficulty of endotracheal intubation
  • Intubation time

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adult patient undergoing elective surgery with general anesthesia

Exclusion criteria

A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.

Treatment and study plan

Paratracheal pressure

Procedure

Paratracheal pressure is applied by 30N force with the ultrasound transducer.

Sellick's maneuver

Procedure

Conventional Sellick's maneuver is applied by 30N force

Primary outcomes

  1. Cormack-Lehane grade

    Time frame: During anesthesia induction procedure

    Cormack-Lehane grade

Secondary outcomes

  1. POGO

    Time frame: During anesthesia induction procedure

    The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%, higher value represent a better view

  2. Difficulty of mask ventilation

    Time frame: During anesthesia induction procedure

    Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)

  3. Inspiration pressure

    Time frame: During anesthesia induction procedure

    Pressure to maintain adequated ventilation after application of the intervention

  4. Tidal volume

    Time frame: During anesthesia induction procedure

    Tidal volume which is achieved after application of the intervention

  5. Intubation difficulty

    Time frame: During anesthesia induction procedure

    Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2019
Registry last updated
Nov 3, 2020

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.

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