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The Effect of Paratracheal Pressure on the Glottic View

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03908411
Enrollment
140
Registered
2019-04-09
Start date
2019-09-05
Completion date
2020-02-28
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paratracheal Pressure, Sellick's Maneuver, Airway Management, Cricoid Pressure

Keywords

Paratracheal pressure

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

Interventions

PROCEDURESellick's maneuver

Conventional Sellick's maneuver is applied by 30N force

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Cormack-Lehane gradeDuring anesthesia induction procedureCormack-Lehane grade

Secondary

MeasureTime frameDescription
POGODuring anesthesia induction procedureThe percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%, higher value represent a better view
Difficulty of mask ventilationDuring anesthesia induction procedureDifficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
Inspiration pressureDuring anesthesia induction procedurePressure to maintain adequated ventilation after application of the intervention
Tidal volumeDuring anesthesia induction procedureTidal volume which is achieved after application of the intervention
Intubation difficultyDuring anesthesia induction procedureSubjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026