Video Stylet vs. Flexible Bronchoscopy for C-Spine

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992092
• Other study ID #: ReDa 7685
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: Timothy Turkstra, MD
• Phone: 5196858500
• Email: timothy.turkstra[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication
• Intubation;Difficult

Intervention

Device:
• C-MAC VS
C-MAC Video Stylet
• Flexible Bronchoscopy
Flexible Bronchoscopy

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intubation	Duration of Intubation	Concurrent, during the intubation
Secondary	C-Spine Movement	Degrees of C-Spine Movement as measured via Fluoroscope	Concurrent, during the intubation
Secondary	Sore Throat	Sore Throat rated as none, mild, moderate, or Severe	24-48 hours post-op.
Secondary	Vocal Changes	Vocal Changes rated as none, mild, moderate, or Severe	24-48 hours post-op.
Secondary	Ease of Intubation	Duration of Intubation, scored on a 100 mm VAS	Concurrent, during the intubation