NCT03226002

Brief Summary

After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2017

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 18, 2017

Last Update Submit

August 6, 2018

Conditions

Nasotracheal Intubation

Keywords

Airtraq NTnasotracheal intubationrightleft

Outcome Measures

Primary Outcomes (3)

  • insertion time of the device

    handling the device till the optimal glottis visualization occurred

    20 seconds

  • nasotracheal intubation time with the device

    handling the device till the visualization of tracheal tube through the vocal cords

    30 seconds

  • total nasotracheal intubation time with the device

    handling the device till the confirmation of nasotracheal intubation with end-tidal carbodioxide

    40 seconds

Secondary Outcomes (2)

  • optimisation maneuvers during intubation with the device

    20 seconds

  • minor complications related to the device

    40 seconds

Study Arms (2)

Airtraq NT right nostril

ACTIVE COMPARATOR

nasotracheal intubation with Airtraq NT through the right nostril

Device: Airtraq NT

Airtraq NT left nostril

ACTIVE COMPARATOR

nasotracheal intubation with Airtraq NT through the left nostril

Device: Airtraq NT

Interventions

Airtraq NTDEVICE

channeled video laryngoscope for nasotracheal intubation

Airtraq NT left nostrilAirtraq NT right nostril

Eligibility Criteria

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

You may qualify if:

  • years of age
  • undergoing elective maxillofacial surgery
  • dental surgery
  • plastic surgery requiring nasotracheal intubation
  • ASA I-II

You may not qualify if:

  • \>18 years and \> 65 years
  • BMI\> 35
  • ASA III-IV
  • fasted patients
  • patients do not require nasotracheal intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

Study Officials

  • zehra I Arslan

    Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

April 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 10, 2017

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)