NCT02418741

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

October 12, 2014

Last Update Submit

April 18, 2015

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • Laryngeal view as index of ease of insertion

    Cormack Lehane grade during endotracheal intubation

    one year

Secondary Outcomes (1)

  • Discomfort of anesthesiologist during endotracheal intubation

    one year

Study Arms (1)

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

Neck flexionOTHER

Patient's neck was flexed using a 4 cm or 8 cm height of pillow

Degree of neck flextion

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Center

Seoul, Junggu, South Korea

Location

Study Officials

  • Mija Yun, staff

    National medical center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 12, 2014

First Posted

April 16, 2015

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

KR(1)