Video Stylet vs. Flexible Bronchoscopy for C-Spine

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03992092

Enrollment

Registered

2019-06-20

Start date

2023-06-01

Completion date

2024-12-30

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Intubation;Difficult

Keywords

cervical spine injury

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.

Interventions

DEVICEC-MAC VS

C-MAC Video Stylet

DEVICEFlexible Bronchoscopy

Flexible Bronchoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

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.

Intervention model description

Parallel randomised controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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

Countries

Canada

Contacts

Primary ContactTimothy Turkstra, MD

timothy.turkstra@lhsc.on.ca5196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026