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

NCT03210922 | Completed

• 1 other identifier: 2017-06-009B
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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

Conditions

Orthosis

Keywords

cervical collar, nasoendotracheal intubation, glidescope

Outcome Measures

Primary Outcomes (1)

• Nasointubation Time

  intubation time assisted by Glidescope

  Intraoperative

Secondary Outcomes (2)

• subjective scoring of ease of intubation

  Intraoperative

• magill forceps for nasointubation

  Intraoperative

Study Arms (2)

Collar group

EXPERIMENTAL

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

Device: Miami cervical collar

Non-collar group

NO INTERVENTION

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

Interventions

Miami cervical collar DEVICE

Collar group is put on the Miami cervical collar.

Collar group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou, 112, Taiwan

Location

Study Officials

• Wen-Cheng Huang, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthetic induction and nasotracheal induction are performed by one anesthesiologist. Another anesthesiology calculated the intubation time according to the video recording.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 7, 2017
• Study Start: July 13, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 18, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

TW (1)