C-MAC Videolaryngoscope Intubation and Cervical Spine Motion
Primary Purpose
Intubation;Difficult, Cervical Spinal Cord Injury
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
C-MAC videolaryngoscope intubation
Direct laryngoscope intubation
Sponsored by
About this trial
This is an interventional other trial for Intubation;Difficult focused on measuring C-MAC
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
C-MAC videolaryngoscope intubation -> Direct laryngoscope intubation
Direct laryngoscope intubation -> C-MAC videolaryngoscope intubation
Outcomes
Primary Outcome Measures
Maximum cervical spine motion (degree)
Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
Secondary Outcome Measures
Intubation time
Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'
Number of intubation trial
Check the number of intubation trial
Postoperative complications
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Postoperative complications
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Postoperative complications
Blood tinged endotracheal tube ( yes or no)
Full Information
NCT ID
NCT03567902
First Posted
May 31, 2018
Last Updated
June 22, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03567902
Brief Title
C-MAC Videolaryngoscope Intubation and Cervical Spine Motion
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation;Difficult, Cervical Spinal Cord Injury
Keywords
C-MAC
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
C-MAC videolaryngoscope intubation -> Direct laryngoscope intubation
Arm Title
Group B
Arm Type
Experimental
Arm Description
Direct laryngoscope intubation -> C-MAC videolaryngoscope intubation
Intervention Type
Device
Intervention Name(s)
C-MAC videolaryngoscope intubation
Intervention Description
C-MAC videolaryngoscope intubation
Intervention Type
Device
Intervention Name(s)
Direct laryngoscope intubation
Intervention Description
Direct laryngoscope intubation
Primary Outcome Measure Information:
Title
Maximum cervical spine motion (degree)
Description
Maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
Time Frame
During tracheal intubation time, an expected average of 90 seconds
Secondary Outcome Measure Information:
Title
Intubation time
Description
Check the intubation time (seconds) defines 'from insertion of device to oral cavity of patients to confirm successful intubation'
Time Frame
Within 90 seconds from insertion of device
Title
Number of intubation trial
Description
Check the number of intubation trial
Time Frame
During tracheal intubation time, an expected average of 1 minutes
Title
Postoperative complications
Description
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Time Frame
During PACU stay time expected up to 1 hr
Title
Postoperative complications
Description
Check the postoperative hoarseness, sore throat and numeric rating scale (1-10) we checked sore throat score
Time Frame
24 hr after operation
Title
Postoperative complications
Description
Blood tinged endotracheal tube ( yes or no)
Time Frame
After extubation, immediate postoperative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyesun Paik, MD
Phone
82-2- 2072-2469
Email
molf0917@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
82-2- 2072-2469 Park, Park
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16116013
Citation
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. Erratum In: Anesth Analg. 2005 Oct;101(4):1011.
Results Reference
background
PubMed Identifier
18292443
Citation
Robitaille 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.
Results Reference
background
PubMed Identifier
28244946
Citation
Kim 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.
Results Reference
background
PubMed Identifier
32799791
Citation
Paik 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.
Results Reference
derived
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C-MAC Videolaryngoscope Intubation and Cervical Spine Motion
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