NCT06441175

Brief Summary

Compare the success rate of upper esophageal obstruction with cricoid pressure during videolaryngoscopy and direct laryngoscopy.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jul 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

May 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 28, 2024

Last Update Submit

May 28, 2024

Conditions

Cricoid Pressure

Outcome Measures

Primary Outcomes (1)

  • Success rate of esophageal obstruction during cricoid pressure

    Success rate of esophageal obstruction during cricoid pressure

    During general anesthesia induction

Secondary Outcomes (3)

  • Esophageal diameter

    During cricoid pressure

  • percentage of glottic opening score

    During cricoid pressure

  • Cormack-Lehane grade

    During cricoid pressure

Study Arms (2)

D-V group

EXPERIMENTAL

the group that performs direct laryngoscopy first and then videolaryngoscopy

Other: Intubation device order

V-D group

EXPERIMENTAL

the group that performs videolaryngoscopy first and then directlaryngoscopy

Other: Intubation device order

Interventions

Intubation device orderOTHER

D-V group: the group that performs direct laryngoscopy first and then videolaryngoscopy. V-D group: the group that performs video laryngoscopy first and then directlaryngoscopy."

D-V groupV-D group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled to have general anesthesia with tracheal intubation

You may not qualify if:

  • Gastroesophageal reflux disease, achalasia, bowel obstruction,
  • BMI \> 35 kg/m2
  • Uncontrolled diabetes
  • Pregnancy
  • Previous esophageal, and gastric surgery
  • Dental damage or anticipated difficult airways
  • Who do not consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • TAE KYONG KIM

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TAE KYONG KIM

CONTACT

82-2-870-2519ktkktk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 4, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

June 4, 2024

Record last verified: 2024-05