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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03210922
Other study ID # 2017-06-009B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2017
Est. completion date April 18, 2018

Study information

Verified date May 2019
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 181
Est. completion date April 18, 2018
Est. primary completion date April 13, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Miami cervical collar
Collar group is put on the Miami cervical collar.

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei Beitou

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nasointubation Time intubation time assisted by Glidescope Intraoperative
Secondary subjective scoring of ease of intubation ease of intubation scored with visual analogue scale Intraoperative
Secondary magill forceps for nasointubation whether magill forcepts is required to facilitate nasointubation Intraoperative
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