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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intubation;Difficult focused on measuring C-MAC

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 31, 2018
    Last Updated
    June 22, 2018
    Sponsor
    Seoul National University Hospital
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    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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