Video Stylet vs. Flexible Bronchoscopy for C-Spine | NCT03992092

Studies
Video Stylet vs. Flexible Bronchoscopy for C-Spine

NCT03992092

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Unknown status

Last Update Posted

Mar 28, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Intubation;Difficult
Intubation Complication

Interventions

C-MAC VS
Flexible Bronchoscopy

Countries

Canada

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 17, 2019

First Posted Date

Jun 20, 2019Actual

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

Mar 26, 2024

Last Update Posted Date

Mar 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Turkstra, Associate Professor and Staff Anesthesiologist, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy

Detailed Description

Elective surgical patients who require intubation will be randomised to one of 2 groups:

C-MAC Video Stylet
Flexible Bronchoscopy During intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process.

The intubation will also be timed to determine the duration of the intubation process.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-Mac VS	Experimental	Intubation using the C-MAC Video Stylet	Device: C-MAC VS
FB	Active Comparator	Intubation using the Flexible Bronchoscope	Device: Flexible Bronchoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-MAC VS	Device	C-MAC Video Stylet	C-Mac VS
Flexible Bronchoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Intubation	Duration of Intubation	Concurrent, during the intubation

Secondary Outcomes

Measure	Description	Time Frame
C-Spine Movement	Degrees of C-Spine Movement as measured via Fluoroscope	Concurrent, during the intubation
Sore Throat	Sore Throat rated as none, mild, moderate, or Severe

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective Surgery requiring oral intubation
undergoing elective non-cardiac surgery
American Society of Anesthesiologists physical status 1-3
age 18-80 years

Exclusion Criteria:

gastro-esophageal reflux disease
body mass index > 35 kg/m2
possibility of pregnancy
previous neck surgery
unstable C-spine
known or predicted difficult airway.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timothy Turkstra, MD	Contact	5196858500	35677	timothy.turkstra@lhsc.on.ca

Overall Officials

Name	Affiliation	Role
Timothy Turkstra, MD	LHSC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital	Recruiting	London	Ontario	N6A5A5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

Double

Masking Description

Participants will be blinded, as will Anesthesiologist providing care, but the investigator who performs the intubation will be aware of the intubation technique he used. Similarly, the Radiologist measuring the C-spine movement will be able to see the device on the fluoroscopic images.

Who Masked

ParticipantCare Provider