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

NCT ID: NCT03210922

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2018-04-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Orthosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The anesthetic induction and nasotracheal induction are performed by one anesthesiologist. Another anesthesiology calculated the intubation time according to the video recording.

Study Groups

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Collar group

Standard of anesthetic care and nasointubation with patient wearing the Miami cervical collar.

Group Type EXPERIMENTAL

Miami cervical collar

Intervention Type DEVICE

Collar group is put on the Miami cervical collar.

Non-collar group

Standard of anesthetic care and nasointubation with patient not wearing the Miami cervical collar.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Miami cervical collar

Collar group is put on the Miami cervical collar.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

Principal Investigator, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Cheng Huang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital

Locations

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Taipei Veterans General Hospital

Taipei, Beitou, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2017-06-009B

Identifier Type: -

Identifier Source: org_study_id

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