Cervical Spine SurgeryNCT04578119
Optimal Intubating Technique Using Videolaryngoscopy in Patients With Semi-rigid Neck Collar
A study testing Sliding Intubating Technique in people with Cervical Spine Surgery and Intubation;Difficult, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Surgery, Intubation;Difficult
- What is being tested?
- Sliding Intubating Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2020to 7 Sep 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (over 19 years of age) with ASA class I-III undergoing cervical spine surgery at our institution in the department of spine neurosurgery
Who cannot join
- When rapid sequence induction is required
- When awake intubation is required
- If a subject is on the medication for asthma
- If as subject cannot read or understand the consent form of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sliding Technique and Conventional Technique for Videolaryngoscopy in Patients Undergoing Cervical Spine Surgery With Semi-rigid Neck Collar During Intubation
In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
Read the detailed description
For patients who need to limit the movement of the cervical spine, the tracheal intubation becomes difficult because the head must be positioned in the neutral position. Most of all, with a semi-rigid neck collar that maintains the neutral position of the head and neck, movement is limited and the mouth is not well-opened make the environment of tracheal intubation worse, which result in hypoxia or throat complications related to general anesthesia. Fortunately, it is possible that the development of video laryngoscope assists tracheal intubation easier for patients who have the limited movement of the cervical spine. However, the preferred intubation style and instrument selection for each operator are varied; the established method is required. In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
- Conditions
- Cervical Spine Surgery, Intubation;Difficult
- Being tested
- Sliding Intubating Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sliding Intubating TechniqueProcedure or surgery
Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Intubating Technique | No intervention | 'Conventional technique' means that endotracheal intubation is performed with the videolayngoscope blade lifting up the epiglottis. |
| Sliding Intubating Technique | Experimental | 'Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly. Receives: Procedure: Sliding Intubating Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of glottic opening (POGO) score (%)
The POGO score represents the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch.
Measured: When we insert the endotracheal tube during anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Oct 2020
- Primary completion31 Aug 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578119
- Sponsor's protocol ID
- 3-2020-0318
- Status last verified
- May 2022
- First submitted
- 23 Sep 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sliding Technique and Conventional Technique for Videolaryngoscopy in Patients Undergoing Cervical Spine Surgery With Semi-rigid Neck Collar During Intubation
- ClinicalTrials.gov ID
- NCT04578119
- Acronym / sponsor ID
- 3-2020-0318
- Conditions
- Cervical Spine Surgery, Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 8 Oct 2020 (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.
In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
Detailed description
For patients who need to limit the movement of the cervical spine, the tracheal intubation becomes difficult because the head must be positioned in the neutral position. Most of all, with a semi-rigid neck collar that maintains the neutral position of the head and neck, movement is limited and the mouth is not well-opened make the environment of tracheal intubation worse, which result in hypoxia or throat complications related to general anesthesia. Fortunately, it is possible that the development of video laryngoscope assists tracheal intubation easier for patients who have the limited movement of the cervical spine. However, the preferred intubation style and instrument selection for each operator are varied; the established method is required. In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Intubating Technique | No intervention | –'Conventional technique' means that endotracheal intubation is performed with the videolayngoscope blade lifting up the epiglottis. |
| Sliding Intubating Technique | Experimental | Procedure: Sliding Intubating Technique'Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (over 19 years of age) with ASA class I-III undergoing cervical spine surgery at our institution in the department of spine neurosurgery
Key exclusion criteria (4 listed)
- When rapid sequence induction is required
- When awake intubation is required
- If a subject is on the medication for asthma
- If as subject cannot read or understand the consent form of study
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 |
|---|---|---|
| Sliding Intubating TechniqueSliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly. | Procedure or surgery | Sliding Intubating Technique |
Primary outcome
percentage of glottic opening (POGO) score (%)
Time frame: When we insert the endotracheal tube during anesthetic induction
The POGO score represents the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch.
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 11 May 2022.
Related trials for Cervical Spine Surgery
RecruitingObservational study
ACSS Approach on Dysphagia
Anterior Cervical Spine Surgery
Recruiting
Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Cervical Spinal Stenosis, Posterior Cervical Spine Surgery
Active, not recruiting
Minimally Invasive Posterior Decompression of the Cervical Spine
Cervical Degenerative Disc Disease, Cervical Stenosis
Recruiting
Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
Cervical Spine Degeneration, ACDF Surgery
Recruiting
Multifidus Cervicis and Inter-Semispinal Plane Blocks in Analgesia After Cervical Spine Surgery
Cervical Spine Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sliding Intubating Technique in people with Cervical Spine Surgery and Intubation;Difficult, run by Gangnam Severance Hospital at 1 site in South Korea.
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 4 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 11 May 2022. 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 South Korea. 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?
percentage of glottic opening (POGO) score (%) (time frame: When we insert the endotracheal tube during anesthetic induction). 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 11 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.