Intubation;DifficultNCT03992092
Video Stylet vs. Flexible Bronchoscopy for C-Spine
A study testing C-MAC VS and Flexible Bronchoscopy in people with Intubation;Difficult and Intubation Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation;Difficult, Intubation Complication
- What is being tested?
- C-MAC VS and Flexible Bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Surgery requiring oral intubation
- undergoing elective non-cardiac surgery
- American Society of Anesthesiologists physical status 1-3
- age 18-80 years
Who cannot join
- gastro-esophageal reflux disease
- body mass index > 35 kg/m2
- possibility of pregnancy
- previous neck surgery
- unstable C-spine
- known or predicted difficult airway.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Hospital
London, Ontario, N6A5A5
T Turkstra, 5196858500 ext. 35677
About this study
Official title: 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
Read the detailed description
Elective surgical patients who require intubation will be randomised to one of 2 groups:
- C-MAC Video Stylet
- 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.
- Conditions
- Intubation;Difficult, Intubation Complication
- Being tested
- C-MAC VS, Flexible Bronchoscopy
- Keywords
- cervical spine injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC VSDevice
C-MAC Video Stylet
Flexible BronchoscopyDevice
Flexible Bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| C-Mac VS | Experimental | Intubation using the C-MAC Video Stylet Receives: Device: C-MAC VS |
| FB | Active comparator | Intubation using the Flexible Bronchoscope Receives: Device: Flexible Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Duration of Intubation
Measured: Concurrent, during the intubation
Secondary outcomes (4)
C-Spine Movement
Degrees of C-Spine Movement as measured via Fluoroscope
Measured: Concurrent, during the intubation
Sore Throat
Sore Throat rated as none, mild, moderate, or Severe
Measured: 24-48 hours post-op.
Vocal Changes
Vocal Changes rated as none, mild, moderate, or Severe
Measured: 24-48 hours post-op.
Ease of Intubation
Duration of Intubation, scored on a 100 mm VAS
Measured: Concurrent, during the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Turkstra, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Timothy Turkstra, MD, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992092
- Sponsor's protocol ID
- ReDa 7685
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury
- ClinicalTrials.gov ID
- NCT03992092
- Acronym / sponsor ID
- ReDa 7685
- Conditions
- Intubation;Difficult, Intubation Complication
- Keywords
- cervical spine injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- C-MAC Video Stylet
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| C-Mac VS | Experimental | Device: C-MAC VSIntubation using the C-MAC Video Stylet |
| FB | Active comparator | Device: Flexible BronchoscopyIntubation using the Flexible Bronchoscope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective Surgery requiring oral intubation
- undergoing elective non-cardiac surgery
- American Society of Anesthesiologists physical status 1-3
- age 18-80 years
Key exclusion criteria (6 listed)
- gastro-esophageal reflux disease
- body mass index > 35 kg/m2
- possibility of pregnancy
- previous neck surgery
- unstable C-spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-MAC VSC-MAC Video Stylet | Device | C-Mac VS |
| Flexible BronchoscopyFlexible Bronchoscopy | Device | FB |
Primary outcome
Time to Intubation
Time frame: Concurrent, during the intubation
Duration of Intubation
4 secondary outcomes
C-Spine Movement
Time frame: Concurrent, during the intubation
Sore Throat
Time frame: 24-48 hours post-op.
Vocal Changes
Time frame: 24-48 hours post-op.
Ease of Intubation
Time frame: Concurrent, during the intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Turkstra, MD principal investigator
LHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC VS and Flexible Bronchoscopy in people with Intubation;Difficult and Intubation Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy Turkstra, MD (5196858500 ext. 35677, timothy.turkstra@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Intubation (time frame: Concurrent, during the intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.