Video Stylet vs. Flexible Bronchoscopy for C-Spine

Not Applicable

Recruiting

• Conditions: Intubation;Difficult; Intubation Complication
• Interventions: Device: C-MAC VS; Device: Flexible Bronchoscopy

• Registration Number: NCT03992092
• Lead Sponsor: Lawson Health Research Institute

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:

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 Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-20
• Study Start: 2023-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-Mac VS	C-MAC VS	Intubation using the C-MAC Video Stylet
FB	Flexible Bronchoscopy	Intubation using the Flexible Bronchoscope

Primary Outcome Measures

Name	Time	Method
Time to Intubation	Concurrent, during the intubation	Duration of Intubation

Secondary Outcome Measures

Name	Time	Method
Vocal Changes	24-48 hours post-op.	Vocal Changes rated as none, mild, moderate, or Severe
Ease of Intubation	Concurrent, during the intubation	Duration of Intubation, scored on a 100 mm VAS
C-Spine Movement	Concurrent, during the intubation	Degrees of C-Spine Movement as measured via Fluoroscope
Sore Throat	24-48 hours post-op.	Sore Throat rated as none, mild, moderate, or Severe

Trial Locations

Locations (1)

University Hospital; 🇨🇦 London, Ontario, Canada