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
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
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
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
Learn more about this trial
The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment
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