Semirigid Cervical Collar and Nasotracheal Intubation by... | NCT03210922

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

NCT03210922

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

181Actual

Phase

Not Applicable

Conditions

Orthosis

Interventions

Miami cervical collar

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2017Actual

Primary Completion Date

Apr 13, 2018Actual

Completion Date

Apr 18, 2018Actual

First Submitted Date

Jun 19, 2017

First Submission Date that Met QC Criteria

Jul 5, 2017

First Posted Date

Jul 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2019

Last Update Posted Date

May 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

vghtpe user, Principal Investigator, Associate Professor, Taipei Veterans General Hospital, TaiwanPrincipal Investigator

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Miami cervical collar	Device	Collar group is put on the Miami cervical collar.	Collar group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wen-Cheng Huang, M.D., Ph.D.	Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veterans General Hospital		Taipei	Beitou	112	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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 Info

Masking

Single

Masking Description

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

Who Masked

Outcomes Assessor