The Effect of Paratracheal Pressure on the Glottic View

Not Applicable

Completed

• Conditions: Sellick's Maneuver; Paratracheal Pressure; Airway Management; Cricoid Pressure
• Interventions: Procedure: Paratracheal pressure; Procedure: Sellick's maneuver

• Registration Number: NCT03908411
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Study Start: 2019-09-05
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paratracheal pressure	Paratracheal pressure	Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.
Sellick's maneuver	Sellick's maneuver	Conventional Sellick's maneuver is applied.

Primary Outcome Measures

Name	Time	Method
Cormack-Lehane grade	During anesthesia induction procedure	Cormack-Lehane grade

Secondary Outcome Measures

Name	Time	Method
Intubation difficulty	During anesthesia induction procedure	Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult
Difficulty of mask ventilation	During anesthesia induction procedure	Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
POGO	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
Inspiration pressure	During anesthesia induction procedure	Pressure to maintain adequated ventilation after application of the intervention
Tidal volume	During anesthesia induction procedure	Tidal volume which is achieved after application of the intervention

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG - SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of