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

Effect of Semirigid Cervical Collar During Nasotracheal Intubation by Glidescope in the Elective Cervical Spinal Surgical Patients: a Study of Clinical Predictors and Outcomes

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

Study Overview

• Status: Completed
• Conditions: Orthosis
• Intervention / Treatment: Device: Miami cervical collar

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Beitou
    • Taipei, Beitou, Taiwan, 112
      • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasointubation Time	intubation time assisted by Glidescope	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective scoring of ease of intubation	ease of intubation scored with visual analogue scale	Intraoperative
magill forceps for nasointubation	whether magill forcepts is required to facilitate nasointubation	Intraoperative

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Wen-Cheng Huang, M.D., Ph.D., Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2017
• Primary Completion (ACTUAL): April 13, 2018
• Study Completion (ACTUAL): April 18, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: cervical collar, nasoendotracheal intubation, glidescope
• Other Study ID Numbers: 2017-06-009B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No