NCT03120546

Brief Summary

In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

April 14, 2017

Last Update Submit

February 12, 2018

Conditions

Intubation

Keywords

cervical spine motionvideo laryngoscoperigid video stylet

Outcome Measures

Primary Outcomes (1)

  • maximum cervical spine motion

    maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments

    during tracheal intubation

Secondary Outcomes (2)

  • intubation time

    during tracheal intubation

  • number of intubation trial

    during tracheal intubation

Study Arms (2)

Group A

EXPERIMENTAL

rigid video stylet intubation - video laryngoscope intubation

Device: rigid video stylet intubationDevice: video laryngoscope intubation

Group B

EXPERIMENTAL

video laryngoscope intubation - rigid video stylet intubation

Device: rigid video stylet intubationDevice: video laryngoscope intubation

Interventions

rigid video stylet intubationDEVICE

intubation using rigid video stylet

Group AGroup B
video laryngoscope intubationDEVICE

intubation using video laryngoscope

Group AGroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite

You may not qualify if:

  • Patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma
  • Patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a Hunt Hess grade of 3-5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • Tae Kyong Kim, M.D., Ph. D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

July 25, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)