Factors Associated With Occluding the Upper Esophagus by... | NCT06210867

Studies
Factors Associated With Occluding the Upper Esophagus by Paratracheal Force

NCT06210867

Sponsor

SMG-SNU Boramae Medical Center

Status

Unknown status

Last Update Posted

Feb 14, 2024Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Intubation Complication

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 8, 2024

First Submission Date that Met QC Criteria

Jan 8, 2024

First Posted Date

Jan 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Measure the sternomental distance, thyromental distance, neck length, neck circumference, Mallampati score, BMI, Neck motion, inter-incisor gap, thyrosternal distance. And analysis these factors are associated with upper esophageal occlusion or not.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of esophageal occlusion rate	Esophageal occlusion is defined as passing an esophageal stethoscope	10 sec

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 19 years old
schedule for general anesthesia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Young Hwang, MD,PhD	Contact	82-2-870-2851		mistyblue15@naver.com

Overall Officials

Name	Affiliation	Role
Jin-Young Hwang, MD,PhD	SMG-SNU Boramae Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jin-Young Hwang		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8424572	Background	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.
17122571	Background	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.