Video Stylet vs. Flexible Bronchoscopy for C-Spine

Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury

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

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication; Intubation;Difficult
• Intervention / Treatment: Device: C-MAC VS; Device: Flexible Bronchoscopy

Detailed Description

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

1. C-MAC Video Stylet
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Turkstra, MD; Phone Number: 35677 5196858500; Email: timothy.turkstra@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Recruiting
      • University Hospital
      • Contact: T Turkstra; Phone Number: 35677 5196858500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-Mac VS; Intubation using the C-MAC Video Stylet	Device: C-MAC VS; C-MAC Video Stylet
Active Comparator: FB; Intubation using the Flexible Bronchoscope	Device: Flexible Bronchoscopy; Flexible Bronchoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	24-48 hours post-op.
Vocal Changes	Vocal Changes rated as none, mild, moderate, or Severe	24-48 hours post-op.
Ease of Intubation	Duration of Intubation, scored on a 100 mm VAS	Concurrent, during the intubation

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Timothy Turkstra, MD, LHSC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cervical spine injury
• Other Study ID Numbers: ReDa 7685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No