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The Effect of Paratracheal Pressure on the Glottic View

NCT ID: NCT03908411

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2020-02-28

Brief Summary

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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

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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

Conditions

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Paratracheal Pressure Sellick's Maneuver Airway Management Cricoid Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Paratracheal pressure

Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.

Group Type ACTIVE_COMPARATOR

Paratracheal pressure

Intervention Type PROCEDURE

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

Sellick's maneuver

Conventional Sellick's maneuver is applied.

Group Type ACTIVE_COMPARATOR

Sellick's maneuver

Intervention Type PROCEDURE

Conventional Sellick's maneuver is applied by 30N force

Interventions

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Paratracheal pressure

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

Intervention Type PROCEDURE

Sellick's maneuver

Conventional Sellick's maneuver is applied by 30N force

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

SMG - SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Won D, Kim H, Chang JE, Lee JM, Min SW, Ma S, Kim C, Hwang JY, Kim TK. Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy: A Randomized Double-Blind, Noninferiority Trial. Anesth Analg. 2021 Aug 1;133(2):491-499. doi: 10.1213/ANE.0000000000005620.

Reference Type DERIVED
PMID: 34081034 (View on PubMed)

Other Identifiers

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10-2019-16

Identifier Type: -

Identifier Source: org_study_id