NCT03999866

Brief Summary

preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

June 25, 2019

Last Update Submit

October 21, 2019

Conditions

AssessmentDifficult Airway IntubationPreoperative

Keywords

airtraqc-macd-blademcgarth mac x-bladepredictiondifficult airway

Outcome Measures

Primary Outcomes (1)

  • satisfaction of the instructor: visual analogy scale

    visual analogy scale of the satisfaction

    2 minutes

Secondary Outcomes (2)

  • satisfaction of the patient: visual analogy scale

    2 minutes

  • duration view

    10 seconds

Study Arms (3)

satisfaction of instructor

ACTIVE COMPARATOR

visual analogy scale of the satisfaction of the instructor was recorded

Device: airtraqDevice: mcgrath mac x-bladeDevice: storz c-macDevice: storz d-blade

satisfaction of the patient

ACTIVE COMPARATOR

visual analogy scale of the satisfaction of the patient was recorded

Device: airtraqDevice: mcgrath mac x-bladeDevice: storz c-macDevice: storz d-blade

duration of view

ACTIVE COMPARATOR

duration of the visualization the vocal cords was recorded

Device: airtraqDevice: mcgrath mac x-bladeDevice: storz c-macDevice: storz d-blade

Interventions

airtraqDEVICE

airtraq videolaryngoscope

Also known as: videolaryngoscope
duration of viewsatisfaction of instructorsatisfaction of the patient
mcgrath mac x-bladeDEVICE

mcgarth mac videolaryngoscope

Also known as: videolaryngoscope
duration of viewsatisfaction of instructorsatisfaction of the patient
storz c-macDEVICE

storz c-mac videolaryngoscope

Also known as: videolaryngoscope
duration of viewsatisfaction of instructorsatisfaction of the patient
storz d-bladeDEVICE

storz d-blade video laryngoscope

Also known as: videolaryngoscope
duration of viewsatisfaction of instructorsatisfaction of the patient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index \< 30
  • no difficult airway history or predictor,
  • no respiratory tract infections for ten days,

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

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

July 1, 2019

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)