Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes

October 21, 2019 updated by: Zehra Ipek ARSLAN, Kocaeli University

Awake Airway Assessment With Video Laryngoscopes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.

We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Kocaeli University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- > 18 years or <60 years of age,

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

Exclusion Criteria: BMI > 35, < 18 or > 60 years of age, expected difficult airway, pregnant

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: satisfaction of instructor
visual analogy scale of the satisfaction of the instructor was recorded
Device: airtraq
airtraq videolaryngoscope
Other Names:
  • videolaryngoscope
Device: mcgrath mac x-blade
mcgarth mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz c-mac
storz c-mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz d-blade
storz d-blade video laryngoscope
Other Names:
  • videolaryngoscope
ACTIVE_COMPARATOR: satisfaction of the patient
visual analogy scale of the satisfaction of the patient was recorded
Device: airtraq
airtraq videolaryngoscope
Other Names:
  • videolaryngoscope
Device: mcgrath mac x-blade
mcgarth mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz c-mac
storz c-mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz d-blade
storz d-blade video laryngoscope
Other Names:
  • videolaryngoscope
ACTIVE_COMPARATOR: duration of view
duration of the visualization the vocal cords was recorded
Device: airtraq
airtraq videolaryngoscope
Other Names:
  • videolaryngoscope
Device: mcgrath mac x-blade
mcgarth mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz c-mac
storz c-mac videolaryngoscope
Other Names:
  • videolaryngoscope
Device: storz d-blade
storz d-blade video laryngoscope
Other Names:
  • videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction of the instructor: visual analogy scale
Time Frame: 2 minutes
visual analogy scale of the satisfaction
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction of the patient: visual analogy scale
Time Frame: 2 minutes
visual analogy scale of the satisfaction
2 minutes
duration view
Time Frame: 10 seconds
time frame from the device enter the oral cavity till the vocal cords visualized
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Study Chair: Zehra I Arslan, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KİA 2019/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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