NCT03709524

Brief Summary

Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

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 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

October 12, 2018

Last Update Submit

June 26, 2019

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    entering the oral cavity till intubation

    6 months

Secondary Outcomes (1)

  • insertion time

    6 months

Study Arms (2)

insertion time

ACTIVE COMPARATOR

1 minute Airtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic

Device: Airtraq + fiberopticDevice: AirtraqDevice: Nasotracheal Airtraq + styletted tube

intubation time

ACTIVE COMPARATOR

2 minutesAirtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic

Device: Airtraq + fiberopticDevice: AirtraqDevice: Nasotracheal Airtraq + styletted tube

Interventions

Airtraq + fiberopticDEVICE

video laryngoscope with a monitor

Also known as: videolaryngoscope
insertion timeintubation time
AirtraqDEVICE

video laryngoscope with a monitor

Also known as: videolaryngoscope
insertion timeintubation time
Nasotracheal Airtraq + styletted tubeDEVICE

video laryngoscope with a monitor

Also known as: videolaryngoscope
insertion timeintubation time

Eligibility Criteria

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

You may qualify if:

  • BMI\<30
  • \> 18 AGE
  • requiring endotracheal intubation
  • ASA 1-2

You may not qualify if:

  • BMI\> 30
  • \< 18 AGE
  • ASA III-IV
  • upper respiratory infection past ten days
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Optical Fibers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and Supplies

Study Design

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

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 17, 2018

Study Start

October 15, 2018

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)