NCT02588157

Brief Summary

Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

October 26, 2015

Last Update Submit

July 19, 2016

Conditions

Rapid Sequence Induction Intubation

Keywords

Rapid sequence induction intubationMcGrath X-BladeGlidescopeMacintosh

Outcome Measures

Primary Outcomes (2)

  • cormack lehane grade with cricoid pressure

    1 minutes

  • intubation time

    2 minutes

Study Arms (2)

İnsertion time

ACTIVE COMPARATOR

handling the device till the glottic visualisation of Macintosh, McGrath MAC X-Blade and Glidescope

Device: MacintoshDevice: GlidescopeDevice: McGrath MAC X-Blade

intubation time

ACTIVE COMPARATOR

handling the device till seeing the endotracheal tube entering from the vocal cords Macintosh, McGrath MAC X-Blade and Glidescope

Device: MacintoshDevice: GlidescopeDevice: McGrath MAC X-Blade

Interventions

MacintoshDEVICE

Direct laryngoscopy

Also known as: direct laryngoscopy
intubation timeİnsertion time
GlidescopeDEVICE

Glidescope videolaryngoscope

Also known as: videolaryngoscope
intubation timeİnsertion time
McGrath MAC X-BladeDEVICE

McGrath MAC X-Blade videolaryngoscope

Also known as: videolaryngoscope
intubation timeİnsertion time

Eligibility Criteria

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

You may qualify if:

  • ASA I-II
  • BMI\< 30
  • years of age

You may not qualify if:

  • known difficult airway
  • BMI \> 30
  • \< 18 years of age
  • \> 65 years of age
  • known respiratory tract infection in 10 days
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41900, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

TU(1)