Optimal Insertion Depth of FOB for Oral FOB Intubation | NCT05277064

Studies
Optimal Insertion Depth of FOB for Oral FOB Intubation

NCT05277064

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 14, 2022Actual

Enrollment

211Estimated

Phase

Not provided

Conditions

General Anesthesia

Interventions

Oral FOB

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

Mar 2022

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

Mar 7, 2022Estimated

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Jan 26, 2022

First Submission Date that Met QC Criteria

Mar 2, 2022

First Posted Date

Mar 14, 2022Actual

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

Mar 2, 2022

Last Update Posted Date

Mar 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung-Man Lee, Clinical Associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

For oral fiberoptic intubation, the preliminary insertion depth of the fiberoptic bronchoscope should be important because the excessive insertion depth or too shallow depth might be the reason why the clinicians cannot perform oral fiberoptic intubation completely.

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

Detailed Description

The purpose of the study is to find out the optimal preliminary insertion depth of the fiberoptic bronchoscope for visualization of glottic opening in oral fiberoptic intubation.

The investigators will enroll the subjects of the present study after obtaining the written consent.

After enrollment, the investigators will measure some anatomical distance, such as patient height.

After induction of anesthesia and muscle relaxation for tracheal intubation, An investigator who has experiences of numerous fiberoptic intubation will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope from the philtrum, the upper lip, or the incisors for oral fiberoptic intubation, with the aid of assistants. Then, tracheal intubation with a laryngoscope as a routine manner of our institute.

The investigators will calculate the mean value of the optimal depth and find out an formula for that from our data.

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

211Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral FOB	Other	After induction of anesthesia and muscle relaxation, An investigator who has experiences of numerous fiberoptic intubations will measure the optimal preliminary insertion depth of the fiberoptic bronchoscope for oral fiberoptic intubation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The length of optimal preliminary insertion depth of FOB (centimeters)	The length of optimal preliminary insertion depth of FOB means the insertion depth of it from the philtrum, the upper lip, or the incisors where the clinicians can see easily the glottic opening while they are flexing the FOB. And that will be recorded as centimeters.	during tracheal intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients requiring tracheal intubation for general anesthesia

Exclusion Criteria:

do not agree to participate in the study
emergency surgery
predicted difficult intubation
very weak teeth (especially central teeth)

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

Adult patients requiring tracheal intubation for general anesthesia without exclusion criteria of our study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Man Lee, MD.PhD	Contact	+82-2-870-2513		jungman007@gmail.com

Overall Officials

Name	Affiliation	Role
Jung-Man Lee, MD.PhD	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul		07061	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

If there will be a reasonable request, we will provide the study data after approval of that from the IRB of our institute.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided