- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188807
The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment
November 15, 2023 updated by: Gülencan Yumuşak Ergin, Ankara University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
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
-
-
-
Ankara, Turkey
- Ankara 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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The patient with cervical pathology
we will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery
|
we will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubation time in seconds
Time Frame: 10 minutes
|
for assessing the degree of difficulty in intubation
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
distance of measurements of airway
Time Frame: 10 minutes
|
ultrasonographic measurements such as skin epiglottis distance, skin hyoid distance, epiglottis to vocal cords distance, hyomental distance
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gülencan YUMUŞAK ERGİN, Ankara 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)
August 1, 2021
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
December 4, 2021
First Submitted That Met QC Criteria
December 26, 2021
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GErgin
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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