NCT02642367

Brief Summary

The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

December 22, 2015

Last Update Submit

November 21, 2016

Conditions

Orotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • intubation time

    time the blade passed the lips until endtidal CO2 was detected

    2 min after rocuronium injection

Study Arms (2)

no use of stylet

EXPERIMENTAL

Endotracheal intubation was performed 2 min after rocuronium injection without use of stylet with McGrath videolaryngoscope after endotracheal tube was rolled up circularly for 3 min

Device: McGrath videolaryngoscopeDrug: rocuronium

use of stylet

ACTIVE COMPARATOR

Endotracheal intubation was performed 2 min after rocuronium injection using a styletted endotracheal tube with McGrath videolaryngoscope

Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)Drug: rocuronium

Interventions

McGrath videolaryngoscopeDEVICE

without use of stylet

no use of stylet
McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)DEVICE

use of stylet

use of stylet
rocuroniumDRUG

tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope

Also known as: rocumeron
no use of styletuse of stylet

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery

You may not qualify if:

  • cervical spine injury
  • rapid sequence induction
  • body mass index\> 35 kg/m2
  • airway pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Location

Ajou University Hospital

Suwon, 443-721, South Korea

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jong Yeop Kim

    Ajou University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate profefssor

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 30, 2015

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

KR(2)