Glottic Visualisation During Laryngoscopy

June 16, 2020 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

The Effect of Head Position on Glottic Visualisation and Intubation Success With Videolaryngoscope in Obese Patients

In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tree different head and neck positions will compare for glottic visualization and intubation success rates in obese patients (BMI> 30 kg / m2) who required endotracheal intubation for general anesthesia between 18-65 years of age.

Study Type

Interventional

Enrollment (Actual)

150

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
    • Merkez
      • Tokat, Merkez, Turkey, 60100
        • Gaziosmanpasa University Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 18-65 aged
  • Being obese
  • Undergoing surgery under general anesthesia

Exclusion Criteria:

  • Having difficult airway
  • Being American Society of Anesthesiologist (ASA) 4 physical status
  • Undergoing emergency surgery

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutral Position
Head and neck will be on neutral position.
Device: Mcgrath Mac Videolaryngoscope
Patient's laryngoscopy will be done using McGrath Mac video laryngoscope
Active Comparator: Sniffing Position
Head and neck will be on sniffing position
Device: Mcgrath Mac Videolaryngoscope
Patient's laryngoscopy will be done using McGrath Mac video laryngoscope
Active Comparator: Head Extension position
Head will be on simple extension position
Device: Mcgrath Mac Videolaryngoscope
Patient's laryngoscopy will be done using McGrath Mac video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glottic view
Time Frame: During laryngoscopy
the percentage of glottic opening (POGO) and cormack-lehane scores will be used to rate of the glottic view
During laryngoscopy
Intubation Success
Time Frame: During intubation
Intubation attempt number will be recorded
During intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation difficulty
Time Frame: During Laryngoscopy
Intubation Difficulty Scale(IDS) score will be recorded.The IDS score is derived from seven variables. N1 represents the number of additional intubation attempts, N2 represents the number of additional operators, N3 is the number of alternative intubation techniques used; N4 represents the laryngoscopic view, N5 represents the lifting force applied during laryngoscopy, N6 represents the necessity to apply external laryngeal pressure to optimize glottic exposure, N7 represents the mobility of vocal cord. The IDS score is the sum of all variables and ranges from zero to infinity. A score of 0 indicates an easy tracheal intubation. Intubation is considered difficult if the score is greater than 5.
During Laryngoscopy
Intubation time
Time Frame: During Intubation
The duration of the endotracheal tube placement will be recorded
During Intubation

Collaborators and Investigators

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

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Tugba Karaman, MD, Tokat Gaziosmanpasa University

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 10, 2019

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 19-KAEK-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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