Cervical PainNCT05188807
The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment
A study testing Airway ultrasonography in people with Cervical Pain and Cervical Disease, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain, Cervical Disease
- What is being tested?
- Airway ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective cervical surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cervical Pain, Cervical Disease
- Being tested
- Airway ultrasonography
- Keywords
- videolaryngoscopy, quality of intubation, cervical pathology, difficult airway
- Medical subject headings
- Neck Pain, Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway ultrasonographyDiagnostic test
we will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance
| Study group | Role | What they receive |
|---|---|---|
| The patient with cervical pathology | Experimental | we will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery Receives: Diagnostic Test: Airway ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time in seconds
for assessing the degree of difficulty in intubation
Measured: 10 minutes
Secondary outcomes (1)
distance of measurements of airway
ultrasonographic measurements such as skin epiglottis distance, skin hyoid distance, epiglottis to vocal cords distance, hyomental distance
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Aug 2021
- Primary completion30 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülencan Yumuşak Ergin, Ankara University
- Investigators
- Gulencan Yumusak Ergin, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188807
- Sponsor's protocol ID
- GErgin
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05188807
- Acronym / sponsor ID
- GErgin
- Conditions
- Cervical Pain, Cervical Disease
- Keywords
- videolaryngoscopy, quality of intubation, cervical pathology, difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patient with cervical pathology | Experimental | Diagnostic Test: Airway ultrasonographywe will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cervical surgery
Key exclusion criteria (7 listed)
- Patients undergoing emergency surgery
- Cervical tumor patients
- Patients with cognitive dysfunction
- Patients with previous cervical surgery
- Pediatric patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway ultrasonographywe will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance | Diagnostic test | The patient with cervical pathology |
Primary outcome
intubation time in seconds
Time frame: 10 minutes
for assessing the degree of difficulty in intubation
1 secondary outcome
distance of measurements of airway
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Cervical Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulencan Yumusak Ergin principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway ultrasonography in people with Cervical Pain and Cervical Disease, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation time in seconds (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.