NCT06210867

Brief Summary

We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

January 8, 2024

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of esophageal occlusion rate

    Esophageal occlusion is defined as passing an esophageal stethoscope

    10 sec

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were scheduled for general anesthesia without a risk of difficult intubation or a history of head and neck surgery.

You may qualify if:

  • ≥ 19 years old
  • schedule for general anesthesia

You may not qualify if:

  • Limited neck extension
  • Abnormality or anomaly, history of surgery in the neck, esophagus, face, upper airway part.
  • Who has weak teeth
  • Who has pulmonary aspiration risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Young Hwang

Seoul, South Korea

Location

Related Publications (5)

  • Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.

    PMID: 8424572BACKGROUND
  • Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.

    PMID: 17122571BACKGROUND
  • Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.

    PMID: 19304443BACKGROUND
  • Van de Putte P, Vernieuwe L, Jerjir A, Verschueren L, Tacken M, Perlas A. When fasted is not empty: a retrospective cohort study of gastric content in fasted surgical patientsdagger. Br J Anaesth. 2017 Mar 1;118(3):363-371. doi: 10.1093/bja/aew435.

    PMID: 28203725BACKGROUND
  • Gautier N, Danklou J, Brichant JF, Lopez AM, Vandepitte C, Kuroda MM, Hadzic A, Gautier PE. The effect of force applied to the left paratracheal oesophagus on air entry into the gastric antrum during positive-pressure ventilation using a facemask. Anaesthesia. 2019 Jan;74(1):22-28. doi: 10.1111/anae.14442. Epub 2018 Oct 4.

    PMID: 30288741BACKGROUND

Study Officials

  • Jin-Young Hwang, MD,PhD

    SMG-SNU Boramae Medical Center

    STUDY CHAIR

Central Study Contacts

Jin-Young Hwang, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

February 27, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations