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Semirigid Cervical Collar and Nasotracheal Intubation by Glidescope in Cervical Spine Surgery

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ClinicalTrials.gov Identifier: NCT03210922
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes

Condition or disease Intervention/treatment Phase
Orthosis Device: Miami cervical collar Not Applicable

Detailed Description:
Clinically used cervical orthoses can effectively limit cervical spine motion in all direction and provide protection. Among them, the restriction by Miami semirigid collar was superior, with the least tissue-interface pressure of neck. It is one of the most used semirigid collars for patients' protection in the operating theatre. However, the presence of the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/ or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy and requires less technical skill than fiberoptic tracheal intubation. The investigation was to assess the effect of cervical collar on nasotracheal intubation and potential hazard factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled for elective cervical spinal surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients are randomized into one of the two group: the collar group or the non-collar group before anesthetic induction. In the collar group, the patient was put on a Miami cervical collar and then anesthetic induction and nasotracheal intubation are performed. the non-collar group receive the same anesthetic care without a collar as a control.
Masking: Single (Outcomes Assessor)
Masking Description: The anesthetic induction and nasotracheal induction are performed by one anesthesiologist. Another anesthesiology calculated the intubation time according to the video recording.
Primary Purpose: Prevention
Official Title: Effect of Semirigid Cervical Collar During Nasotracheal Intubation by Glidescope in the Elective Cervical Spinal Surgical Patients: a Study of Clinical Predictors and Outcomes
Actual Study Start Date : July 13, 2017
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 18, 2018

Arm Intervention/treatment
Experimental: Collar group
Standard of anesthetic care and nasointubation with patient wearing the Miami cervical collar.
Device: Miami cervical collar
Collar group is put on the Miami cervical collar.

No Intervention: Non-collar group
Standard of anesthetic care and nasointubation with patient not wearing the Miami cervical collar.



Primary Outcome Measures :
  1. Nasointubation Time [ Time Frame: Intraoperative ]
    intubation time assisted by Glidescope


Secondary Outcome Measures :
  1. subjective scoring of ease of intubation [ Time Frame: Intraoperative ]
    ease of intubation scored with visual analogue scale

  2. magill forceps for nasointubation [ Time Frame: Intraoperative ]
    whether magill forcepts is required to facilitate nasointubation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective cervical spine surgery
  • scheduled for nasotracheal intubation
  • not requiring orthosis for prophylactic protection

Exclusion Criteria:

  • Risk of pulmonary aspiration of gastric contents
  • Pathology of the nasal cavity
  • Abnormal coagulation function
  • Extensive and severe cord compression
  • Refused to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210922


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Beitou, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Wen-Cheng Huang, M.D., Ph.D. Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital
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Responsible Party: vghtpe user, Principal Investigator, Associate Professor, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03210922    
Other Study ID Numbers: 2017-06-009B
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
cervical collar, nasoendotracheal intubation, glidescope