Difficult AirwaySTAGENCT01632683
STorz Against Glidescope Effectiveness
A study testing C-MAC and Glidescope in people with Difficult Airway, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- C-MAC and Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult 18 years of age
- Mallampati classification scale score of 3 or 4
- Neck circumference greater than 40cm for males, 38 cm for females
- mouth opening less than 3cm, but greater than 2cm
Who cannot join
- children
- prisoners
- history of easy intubation (success on first attempt with direct laryngoscopy)
- known unstable cervical spine injury
- emergency surgery
- nasal intubation route
- planned awake technique
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.
- Conditions
- Difficult Airway
- Being tested
- C-MAC, Glidescope
- Keywords
- difficult airway, video laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MACDevice
C-MAC arm
GlidescopeDevice
Glidescope arm
| Study group | Role | What they receive |
|---|---|---|
| C-MAC | Active comparator | Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation Receives: Device: C-MAC |
| Glidescope | Active comparator | Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Receives: Device: Glidescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Success Rate
Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide
Measured: 1 week
Secondary outcomes (4)
Intubation Time
Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide
Measured: 1 week
Graded Score of Laryngeal View Achieved
Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.
Measured: 1 week
Number of Particpants Requiring Adjuncts to Assist Intubation
The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.
Measured: 1 week
Number of Participants With Observed Complications
Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Michael Aziz, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632683
- Sponsor's protocol ID
- 62199040
- Acronym
- STAGE
- Status last verified
- Oct 2017
- First submitted
- 14 Jun 2012
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
PubMed 22261795
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway
- ClinicalTrials.gov ID
- NCT01632683
- Acronym / sponsor ID
- STAGE / 62199040
- Conditions
- Difficult Airway
- Keywords
- difficult airway, video laryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Iowa, The University of Texas Health Science Center, Houston
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-MAC | Active comparator | Device: C-MACProviders will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation |
| Glidescope | Active comparator | Device: GlidescopeProviders will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult 18 years of age
- Mallampati classification scale score of 3 or 4
- Neck circumference greater than 40cm for males, 38 cm for females
- mouth opening less than 3cm, but greater than 2cm
Key exclusion criteria (7 listed)
- children
- prisoners
- history of easy intubation (success on first attempt with direct laryngoscopy)
- known unstable cervical spine injury
- emergency surgery
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-MACC-MAC arm | Device | C-MAC |
| GlidescopeGlidescope arm | Device | Glidescope |
Primary outcome
Intubation Success Rate
Time frame: 1 week
Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide
4 secondary outcomes
Intubation Time
Time frame: 1 week
Graded Score of Laryngeal View Achieved
Time frame: 1 week
Number of Particpants Requiring Adjuncts to Assist Intubation
Time frame: 1 week
Number of Participants With Observed Complications
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22261795Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Glidescope in people with Difficult Airway, run by Oregon Health and Science University at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 30 Nov 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation Success Rate (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632683, which also lists 1 linked publication.
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 30 Nov 2017.