Video Stylet vs. Flexible Bronchoscopy for C-Spine

NCT03992092 | Recruiting

• 1 other identifier: ReDa 7685
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation;Difficult; Intubation Complication

Keywords

cervical spine injury

Outcome Measures

Primary Outcomes (1)

• Time to Intubation

  Duration of Intubation

  Concurrent, during the intubation

Secondary Outcomes (4)

• C-Spine Movement

  Concurrent, during the intubation

• Sore Throat

  24-48 hours post-op.

• Vocal Changes

  24-48 hours post-op.

• Ease of Intubation

  Concurrent, during the intubation

Study Arms (2)

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

C-MAC VS DEVICE

C-MAC Video Stylet

C-Mac VS

Flexible Bronchoscopy DEVICE

Flexible Bronchoscopy

FB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital

London, Ontario, N6A5A5, Canada

RECRUITING

Study Officials

• Timothy Turkstra, MD

  LHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Turkstra, MD

CONTACT

5196858500; timothy.turkstra@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Staff Anesthesiologist

Model Details: Parallel randomised controlled trial

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: June 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)