Intubation;DifficultNCT03567902
C-MAC Videolaryngoscope Intubation and Cervical Spine Motion
A study testing C-MAC videolaryngoscope intubation and Direct laryngoscope intubation in people with Intubation;Difficult and Cervical Spinal Cord Injury, run by Seoul National University Hospital.
Trial summary
The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intubation;Difficult, Cervical Spinal Cord Injury
- What is being tested?
- C-MAC videolaryngoscope intubation and Direct laryngoscope intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to May 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists physical status of 1-2 and age of 20-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.
Who cannot join
- Patients with C-spine injury, C-spine disease
- Patients with past medical history of C-spine surgery or intervention
- Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
- Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
- Body mass index > 30
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine
The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.
Read the detailed description
When the intubation is required in patients with an injured cervical spine, securing the airway while minimizing C-spine motion to prevent neurological damage can be very difficult. The awake intubation using a flexible bronchoscope is preferred as it minimizes C-spine motion. However, in the emergent clinical practice, direct laryngoscopy with manual in-line stabilization is most commonly used, because it is quicker and does not require patient collaboration. Numerous alternatives to direct laryngoscopy and fiberoptic bronchoscopy have been studied. But, none of these methods combines the convenience of direct laryngoscopy and the C-spine immobility afforded by intubation using a fiberoptic bronchoscope patient with an injured C-spine.
The videolaryngoscopy has recently developed extensively and become more widely available. It has the potential of combining the advantages of both direct laryngoscopy and intubation using a fiberoptic bronchoscope. Indeed, it provides an indirect view of the glottis, which could diminish C-spine movement, but its handling shares many similarities with direct laryngoscopy, which could make it more convenient than the flexible bronchoscope.
In the previous study examining C-spine movement during direct laryngoscopy and GlideScope® videolaryngoscopy, found no difference in movement at the rostral level but showed significantly less movement of the inferior C-spine with GlideScope® videolaryngoscopy. We postulate that C-MAC videolaryngoscope will induce less movement than direct laryngoscopy. The effect of C-MAC videolaryngoscope intubation technique on cervical spine motion is not investigated yet.
In this study, C-spine stabilization will be provided by Philadelphia neck collar. We will investigate a prospective cinefluoroscopic study comparing C-spine motion during direct laryngoscopy and C-MAC videolaryngoscope in patients with an intact C-spine stabilized by Philadelphia collar.
The duration and maximum change for C-MAC videolaryngoscope intubation technique was compared to those with direct laryngoscopy at each motion segment using a Student's paired t-test.
- Conditions
- Intubation;Difficult, Cervical Spinal Cord Injury
- Being tested
- C-MAC videolaryngoscope intubation, Direct laryngoscope intubation
- Keywords
- C-MAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC videolaryngoscope intubationDevice
C-MAC videolaryngoscope intubation
Direct laryngoscope intubationDevice
Direct laryngoscope intubation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | C-MAC videolaryngoscope intubation -> Direct laryngoscope intubation Receives: Device: C-MAC videolaryngoscope intubation; Device: Direct laryngoscope intubation |
| Group B | Experimental | Direct laryngoscope intubation -> C-MAC videolaryngoscope intubation Receives: Device: C-MAC videolaryngoscope intubation; Device: Direct laryngoscope intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum cervical spine motion (degree)
Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
Measured: During tracheal intubation time, an expected average of 90 seconds
Secondary outcomes (5)
Intubation time
Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'
Measured: Within 90 seconds from insertion of device
Number of intubation trial
Check the number of intubation trial
Measured: During tracheal intubation time, an expected average of 1 minutes
Postoperative complications
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Measured: During PACU stay time expected up to 1 hr
Postoperative complications
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Measured: 24 hr after operation
Postoperative complications
Blood tinged endotracheal tube ( yes or no)
Measured: After extubation, immediate postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- 82-2- 2072-2469 Park, Park, Principal investigator, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567902
- Sponsor's protocol ID
- 1804-123-940
- Status last verified
- Jun 2018
- First submitted
- 31 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.
PubMed 16116013Robitaille A, Williams SR, Tremblay MH, Guilbert F, Theriault M, Drolet P. Cervical spine motion during tracheal intubation with manual in-line stabilization: direct laryngoscopy versus GlideScope videolaryngoscopy. Anesth Analg. 2008 Mar;106(3):935-41, table of contents. doi: 10.1213/ane.0b013e318161769e.
PubMed 18292443Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.
PubMed 28244946Paik H, Park HP. Randomized crossover trial comparing cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope in a simulated immobilized cervical spine. BMC Anesthesiol. 2020 Aug 15;20(1):201. doi: 10.1186/s12871-020-01118-3.
PubMed 32799791
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine
- ClinicalTrials.gov ID
- NCT03567902
- Acronym / sponsor ID
- 1804-123-940
- Conditions
- Intubation;Difficult, Cervical Spinal Cord Injury
- Keywords
- C-MAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 26 Jun 2018 (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.
The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.
Detailed description
When the intubation is required in patients with an injured cervical spine, securing the airway while minimizing C-spine motion to prevent neurological damage can be very difficult. The awake intubation using a flexible bronchoscope is preferred as it minimizes C-spine motion. However, in the emergent clinical practice, direct laryngoscopy with manual in-line stabilization is most commonly used, because it is quicker and does not require patient collaboration. Numerous alternatives to direct laryngoscopy and fiberoptic bronchoscopy have been studied. But, none of these methods combines the convenience of direct laryngoscopy and the C-spine immobility afforded by intubation using a fiberoptic bronchoscope patient with an injured C-spine.
The videolaryngoscopy has recently developed extensively and become more widely available. It has the potential of combining the advantages of both direct laryngoscopy and intubation using a fiberoptic bronchoscope. Indeed, it provides an indirect view of the glottis, which could diminish C-spine movement, but its handling shares many similarities with direct laryngoscopy, which could make it more convenient than the flexible bronchoscope.
In the previous study examining C-spine movement during direct laryngoscopy and GlideScope® videolaryngoscopy, found no difference in movement at the rostral level but showed significantly less movement of the inferior C-spine with GlideScope® videolaryngoscopy. We postulate that C-MAC videolaryngoscope will induce less movement than direct laryngoscopy. The effect of C-MAC videolaryngoscope intubation technique on cervical spine motion is not investigated yet.
In this study, C-spine stabilization will be provided by Philadelphia neck collar. We will investigate a prospective cinefluoroscopic study comparing C-spine motion during direct laryngoscopy and C-MAC videolaryngoscope in patients with an intact C-spine stabilized by Philadelphia collar.
The duration and maximum change for C-MAC videolaryngoscope intubation technique was compared to those with direct laryngoscopy at each motion segment using a Student's paired t-test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: C-MAC videolaryngoscope intubation, Device: Direct laryngoscope intubationC-MAC videolaryngoscope intubation -> Direct laryngoscope intubation |
| Group B | Experimental | Device: C-MAC videolaryngoscope intubation, Device: Direct laryngoscope intubationDirect laryngoscope intubation -> C-MAC videolaryngoscope intubation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists physical status of 1-2 and age of 20-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.
Key exclusion criteria (5 listed)
- Patients with C-spine injury, C-spine disease
- Patients with past medical history of C-spine surgery or intervention
- Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
- Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
- Body mass index > 30
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 |
|---|---|---|
| C-MAC videolaryngoscope intubationC-MAC videolaryngoscope intubation | Device | Group A, Group B |
| Direct laryngoscope intubationDirect laryngoscope intubation | Device | Group A, Group B |
Primary outcome
Maximum cervical spine motion (degree)
Time frame: During tracheal intubation time, an expected average of 90 seconds
Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
5 secondary outcomes
Intubation time
Time frame: Within 90 seconds from insertion of device
Number of intubation trial
Time frame: During tracheal intubation time, an expected average of 1 minutes
Postoperative complications
Time frame: During PACU stay time expected up to 1 hr
Postoperative complications
Time frame: 24 hr after operation
Postoperative complications
Time frame: After extubation, immediate postoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 16116013Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-915. doi: 10.1213/01.ane.0000166975.38649.27.
- Background: PubMed 18292443Robitaille A, Williams SR, Tremblay MH, Guilbert F, Theriault M, Drolet P. Cervical spine motion during tracheal intubation with manual in-line stabilization: direct laryngoscopy versus GlideScope videolaryngoscopy. Anesth Analg. 2008 Mar;106(3):935-41, table of contents. doi: 10.1213/ane.0b013e318161769e.
- Background: PubMed 28244946Kim TK, Son JD, Seo H, Lee YS, Bae J, Park HP. A Randomized Crossover Study Comparing Cervical Spine Motion During Intubation Between Two Lightwand Intubation Techniques in Patients With Simulated Cervical Immobilization: Laryngoscope-Assisted Versus Conventional Lightwand Intubation. Anesth Analg. 2017 Aug;125(2):485-490. doi: 10.1213/ANE.0000000000001813.
- Derived from this study: PubMed 32799791Paik H, Park HP. Randomized crossover trial comparing cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope in a simulated immobilized cervical spine. BMC Anesthesiol. 2020 Aug 15;20(1):201. doi: 10.1186/s12871-020-01118-3.
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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.
82-2- 2072-2469 Park, Park principal investigator
Seoul National University of Hospital
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC videolaryngoscope intubation and Direct laryngoscope intubation in people with Intubation;Difficult and Cervical Spinal Cord Injury, run by Seoul National University Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Pyung Park, MD PhD (82-2-2072-2466, hppark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum cervical spine motion (degree) (time frame: During tracheal intubation time, an expected average of 90 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03567902, which also lists 4 linked publications.
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 26 Jun 2018.