NCT03000088

Brief Summary

The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

December 19, 2016

Results QC Date

January 13, 2017

Last Update Submit

March 2, 2017

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • Time to Intubation

    10 minutes around intubation

Study Arms (2)

60° angle group

intubate using McGrath Videolaryngoscope with 60° angled stylet

Device: intubate with 60° angled stylet

90°angle group

intubate using McGrath Videolaryngoscope with 90° angled stylet

Device: intubate with 60° angled stylet

Interventions

intubate with 60° angled styletDEVICE
60° angle group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients scheduled for elective surgery requiring orotracheal intubation in our hospital

You may qualify if:

  • an American Society of Anesthesiologists physical status (ASA) 1 or 2

You may not qualify if:

  • a suspected difficult airway (Mallampati score Ⅳ)
  • known cervical spine injury
  • required rapid sequence induction
  • emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr. Jiyoung Lee
Organization
Ajou University School of Medicine
leejiyoung0616@gmail.com
82-31-219-5689

Study Officials

  • Jiyoung Lee, MD

    Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant prefessor

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 21, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 13, 2017

Results First Posted

April 13, 2017

Record last verified: 2017-03