NCT02931019

Brief Summary

For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

October 10, 2016

Last Update Submit

May 11, 2017

Conditions

IntubationPosture

Keywords

fiberopticintubationposture

Outcome Measures

Primary Outcomes (1)

  • POGO score

    The percentage of glottic opening

    a week (after get the picture)

Study Arms (2)

neck flexion first

EXPERIMENTAL

With specific head posture, intubation is done under flexible fiberoscopy guide. In this arm, at the position with neck flexion, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck extension, And the laryngeal view is gotten in the same way.

Procedure: Intubation

neck extension first

EXPERIMENTAL

In this arm, at the position with neck extension, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck flexion, And the laryngeal view is gotten in the same way.

Procedure: Intubation

Interventions

IntubationPROCEDURE
neck extension firstneck flexion first

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class 1 or 2
  • scheduled for general anesthesia with endotracheal intubation
  • decided to join this clinical study voluntarily

You may not qualify if:

  • history of difficult intubation
  • anticipated the difficult intubation: Total airway score \> 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
  • risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Related Publications (1)

  • Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.

    PMID: 30611215DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

October 13, 2016

Primary Completion

January 2, 2017

Study Completion

January 2, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

KR(1)