Difficult IntubationNCT02177240
A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.
A study testing GlideScope® intubation with Flex-it® stylet and GlideScope® intubation with GRS® stylet in people with Difficult Intubation, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- GlideScope® intubation with Flex-it® stylet and GlideScope® intubation with GRS® stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Sep 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA status 1-2
- BMI < 35
- Elective surgery
- General Anesthesia
Who cannot join
- Difficult intubation
- Indication for rapid sequence intubation
- Contraindication for cervical collar
Trial locations and contacts
1 site in 1 country.
Issam Tanoubi, MD contact
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
John Nguyen, MD, 514-252-3400 ext. 4558, john.viet.nguyen@umontreal.ca
Issam Tanoubi, MD, 514-252-3400 ext. 4558
About this study
Official title: A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.
The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.
Read the detailed description
Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.
Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.
The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.
The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.
Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.
Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone.
Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure.
The data is then taken from the video and analyzed by a blinded operator.
- Conditions
- Difficult Intubation
- Being tested
- GlideScope® intubation with Flex-it® stylet, GlideScope® intubation with GRS® stylet
- Keywords
- GlideScope®, GlideRite®, Flex-it®, Difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScope® intubation with Flex-it® styletDevice
GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
GlideScope® intubation with GRS® styletDevice
GlideScope® intubation with GRS® stylet of a simulated difficult airway
| Study group | Role | What they receive |
|---|---|---|
| GRS (GlideRite®) | Active comparator | GlideScope® intubation with GRS® stylet of a simulated difficult airway Receives: Device: GlideScope® intubation with GRS® stylet |
| FIS (Flex-it® ) | Active comparator | GlideScope® intubation with Flex-it® stylet of a simulated difficult airway Receives: Device: GlideScope® intubation with Flex-it® stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time from start of laryngoscopy to confirmation of EtCO2
Measured: During intubation
Secondary outcomes (5)
Sore throat/Hoarseness
Scale of 0 to 3
Measured: Day 0 (immediate post-operative)
Sore throat/Hoarseness
Scale of 0 to 3
Measured: Day 1 (24hr post-operative)
Verbal Intubation difficulty scale
Scale of 1 to 10
Measured: 15 minutes after intubation
Tube manipulation time
Time from start of tube manipulation to confirmation of EtCO2
Measured: During Intubation
Resistance during stylet extraction
Scale of 1 to 5
Measured: 15 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Viet Nguyen, Maisonneuve-Rosemont Hospital
- Investigators
- John Viet Nguyen, MD, Principal investigator, HMRIssam Tanoubi, MD, Study director, HMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177240
- Sponsor's protocol ID
- Cér 14013
- Status last verified
- Jun 2014
- First submitted
- 29 May 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02177240
- Acronym / sponsor ID
- Cér 14013
- Conditions
- Difficult Intubation
- Keywords
- GlideScope®, GlideRite®, Flex-it®, Difficult intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- 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.
The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.
Detailed description
Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.
Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.
The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.
The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.
Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.
Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone.
Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure.
The data is then taken from the video and analyzed by a blinded operator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRS (GlideRite®) | Active comparator | Device: GlideScope® intubation with GRS® styletGlideScope® intubation with GRS® stylet of a simulated difficult airway |
| FIS (Flex-it® ) | Active comparator | Device: GlideScope® intubation with Flex-it® styletGlideScope® intubation with Flex-it® stylet of a simulated difficult airway |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA status 1-2
- BMI < 35
- Elective surgery
- General Anesthesia
Key exclusion criteria (3 listed)
- Difficult intubation
- Indication for rapid sequence intubation
- Contraindication for cervical collar
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 |
|---|---|---|
| GlideScope® intubation with Flex-it® styletGlideScope® intubation with Flex-it® stylet of a simulated difficult airway | Device | FIS (Flex-it® ) |
| GlideScope® intubation with GRS® styletGlideScope® intubation with GRS® stylet of a simulated difficult airway | Device | GRS (GlideRite®) |
Primary outcome
Intubation time
Time frame: During intubation
Time from start of laryngoscopy to confirmation of EtCO2
5 secondary outcomes
Sore throat/Hoarseness
Time frame: Day 0 (immediate post-operative)
Sore throat/Hoarseness
Time frame: Day 1 (24hr post-operative)
Verbal Intubation difficulty scale
Time frame: 15 minutes after intubation
Tube manipulation time
Time frame: During Intubation
Resistance during stylet extraction
Time frame: 15 minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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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.
Issam Tanoubi, MD contact
John Viet Nguyen, MD principal investigator
HMR
Issam Tanoubi, MD study director
HMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope® intubation with Flex-it® stylet and GlideScope® intubation with GRS® stylet in people with Difficult Intubation, run by Maisonneuve-Rosemont Hospital 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 3 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 27 Jun 2014. 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 John Viet Nguyen, MD (514-252-3400 ext. 4558, john.viet.nguyen@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: During 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 27 Jun 2014.