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Glottic Visualisation During Laryngoscopy

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ClinicalTrials.gov Identifier: NCT04003727
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, Tokat Gaziosmanpasa University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intubation Device: Mcgrath Mac Videolaryngoscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Effect of Head Position on Glottic Visualisation and Intubation Success With Videolaryngoscope in Obese Patients
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 12, 2020

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




Primary Outcome Measures :
  1. 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

  2. Intubation Success [ Time Frame: During intubation ]
    Intubation attempt number will be recorded


Secondary Outcome Measures :
  1. 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.

  2. Intubation time [ Time Frame: During Intubation ]
    The duration of the endotracheal tube placement will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003727


Locations
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Turkey
Gaziosmanpasa University Hospital
Tokat, Merkez, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Tugba Karaman, MD Tokat Gaziosmanpasa University
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Responsible Party: Tuğba Karaman, Assoc. Prof., Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT04003727    
Other Study ID Numbers: 19-KAEK-085
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No