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The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment

Primary Purpose

Cervical Pain, Cervical Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Airway ultrasonography
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Pain focused on measuring videolaryngoscopy, quality of intubation, cervical pathology, difficult airway

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Elective cervical surgery

Exclusion Criteria:

  • Patients undergoing emergency surgery
  • Cervical tumor patients
  • Patients with cognitive dysfunction
  • Patients with previous cervical surgery
  • Pediatric patients
  • Cervical trauma patients
  • The presence of cervical spondylitis, spondylodiscitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    The patient with cervical pathology

    Arm Description

    we will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery

    Outcomes

    Primary Outcome Measures

    intubation time in seconds
    for assessing the degree of difficulty in intubation

    Secondary Outcome Measures

    distance of measurements of airway
    ultrasonographic measurements such as skin epiglottis distance, skin hyoid distance, epiglottis to vocal cords distance, hyomental distance

    Full Information

    First Posted
    December 4, 2021
    Last Updated
    July 7, 2023
    Sponsor
    Ankara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05188807
    Brief Title
    The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment
    Official Title
    The Correlation of the Cervical Symptoms With Endotracheal Intubation Quality and Preoperative Airway Assessment With Ultrasonography and Magnetic Resonants Imaging, in Patients Operated for Cervical Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2023 (Anticipated)
    Study Completion Date
    December 25, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Cervical spine disorders can cause neck pain with or without neurological dysfunction. The most common cause of acute and chronic neck pain is cervical degenerative changes. Surgical decision of cervical pathology is made by anamnesis, neurological examination and imaging methods. Airway management can be difficult for patients presenting for cervical spine surgery. In addition, these patients may have severe cervical spine instability or spinal cord level myelopathy and may develop serious neurological complications associated with the intubation technique. Videolaringoscopes, which have become widely used with the developing technology, provide a better view than direct laryngoscopy in terms of cervical immobilization during intubation. Therefore, videolaryngoscope is preferred for cervical pathologies. Nowadays, the use of videolaryngoscope is recommended in patients with airway difficulty. Neutral position is important for intubation of patients with cervical pathology and it is highly recommended in the literature to evaluate these patients as difficult airways. All cervical patients are intubated with videolaryngoscope in investigator's clinic. The aim of this study was to evaluate how long the duration of cervical pathology affects airway anatomy and how it affects airway management during anesthesia. On the other hand, airway-related measurements will be performed by MRI and ultrasonography (USG), which is routinely evaluated in the diagnosis process, and it will be aimed to evaluate these measurements in terms of their effects on intubation quality. At the end of the study, all evaluations were analyzed and it was aimed to compare the effects of other evaluated parameters (such as USG and MRI measurements) on intubation difficulty level, with cervical pathology duration being primary.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Pain, Cervical Disease
    Keywords
    videolaryngoscopy, quality of intubation, cervical pathology, difficult airway

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The patient with cervical pathology
    Arm Type
    Experimental
    Arm Description
    we will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Airway ultrasonography
    Intervention Description
    we will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance
    Primary Outcome Measure Information:
    Title
    intubation time in seconds
    Description
    for assessing the degree of difficulty in intubation
    Time Frame
    10 minutes
    Secondary Outcome Measure Information:
    Title
    distance of measurements of airway
    Description
    ultrasonographic measurements such as skin epiglottis distance, skin hyoid distance, epiglottis to vocal cords distance, hyomental distance
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Elective cervical surgery Exclusion Criteria: Patients undergoing emergency surgery Cervical tumor patients Patients with cognitive dysfunction Patients with previous cervical surgery Pediatric patients Cervical trauma patients The presence of cervical spondylitis, spondylodiscitis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment

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