Head Position for Endotracheal Intubation | NCT02418741

Studies
Head Position for Endotracheal Intubation

NCT02418741

Sponsor

National Medical Center, Seoul

Status

Completed

Last Update Posted

Apr 21, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Intubation; Difficult

Interventions

Neck flexion

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Oct 12, 2014

First Submission Date that Met QC Criteria

Apr 15, 2015

First Posted Date

Apr 16, 2015Estimated

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

Apr 18, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mi Ja Yun, MD, PhD, Principal investigator, National Medical Center, SeoulPrincipal Investigator

Lead Sponsor

National Medical Center, SeoulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.

Detailed Description

The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy. There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation. In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Degree of neck flextion	Experimental	Two degrees of neck flexion were achieved using a 4 cm or 8 cm height of pillow	Other: Neck flexion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neck flexion	Other	Patient's neck was flexed using a 4 cm or 8 cm height of pillow	Degree of neck flextion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laryngeal view as index of ease of insertion	Cormack Lehane grade during endotracheal intubation	one year

Secondary Outcomes

Measure	Description	Time Frame
Discomfort of anesthesiologist during endotracheal intubation	Anesthesiologist can feel difficulties in mouth opening and in insertion of laryngoscopic blade into oral cavity according to the degrees of neck flexion	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective operation time ≤2hrs
American Society of Anesthesiologist, Physical Status 1 or 2
age ; 18 - 90 years

Exclusion Criteria:

patient has upper respiratory infection symptoms
limited mouth opening
teeth problems
expecting difficult airway
congenital heart disease
patient has a possibility of aspiration pneumonia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mija Yun, staff	National medical center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Medical Center		Seoul	Junggu		South Korea