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Clinical Trials/NCT03908411
NCT03908411CompletedNot Applicable

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

Seoul National University Hospital4 sites in 1 country140 target enrollmentStarted: September 5, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
4
Primary Endpoint
Cormack-Lehane grade
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Cormack-Lehane grade

Time Frame: During anesthesia induction procedure

Cormack-Lehane grade

Secondary Outcomes

  • Difficulty of mask ventilation(During anesthesia induction procedure)
  • POGO(During anesthesia induction procedure)
  • Inspiration pressure(During anesthesia induction procedure)
  • Tidal volume(During anesthesia induction procedure)
  • Intubation difficulty(During anesthesia induction procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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The Effect of Paratracheal Pressure on the... | Clinical Trial