AirwayNCT01031940
CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.
A study testing macintosh laryngoscope, C-MAC laryngoscope and Airtraq device in people with Airway and Difficult Intubation, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present. The CMAC® Laryngoscope is a new intubating device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway, Difficult Intubation, Airway Device
- What is being tested?
- macintosh laryngoscope, C-MAC laryngoscope and Airtraq device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2010to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
- Written informed Consent
- No relevant drug allergies
- Patients with 2 or more of the following predictors of difficult intubation:
- Mallampatti II - IV
- Thyromental distance < 6cm
Show all 10Show fewer
- Mouth opening < 3.5 cm
- Cervical spine disease
- Anteriorly protruding incisors
- Presence of Caps or Crowns
Who cannot join
- Patients with history of or risk factors for gastric regurgitation
- Patients unable to consent for the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the CMAC® Device to the Airtraq® and the Macintosh Laryngoscope in Patients With Anatomical Characteristics Predictive of Difficult Tracheal Intubation.
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.
The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
Read more
The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.
We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.
The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.
The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.
The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.
- Conditions
- Airway, Difficult Intubation, Airway Device
- Being tested
- macintosh laryngoscope, C-MAC laryngoscope, Airtraq device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macintosh laryngoscopeDevice
intubate with the macintosh laryngoscope
C-MAC laryngoscopeDevice
intubate with the C-MAC laryngoscope
Airtraq deviceDevice
intubate with the Airtraq device
| Study group | Role | What they receive |
|---|---|---|
| macintosh | Active comparator | Not described Receives: Device: macintosh laryngoscope |
| C-MAC | Active comparator | Not described Receives: Device: C-MAC laryngoscope |
| Airtraq | Active comparator | Not described Receives: Device: Airtraq device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful placement of Tube in the Trachea
Measured: immediately
Secondary outcomes (3)
1. Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds
Measured: immediately
2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
Measured: immediately
3. Laryngeal View Obtained c. Cormac and Lehane Grading of Best Laryngeal View d. Change in view compared to initial assessment by independent anaesthetist. e. POGO score.
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Laffey, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031940
- Sponsor's protocol ID
- CMAC-1
- Status last verified
- Jun 2012
- First submitted
- 14 Dec 2009
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the CMAC® Device to the Airtraq® and the Macintosh Laryngoscope in Patients With Anatomical Characteristics Predictive of Difficult Tracheal Intubation.
- ClinicalTrials.gov ID
- NCT01031940
- Acronym / sponsor ID
- CMAC-1
- Conditions
- Airway, Difficult Intubation, Airway Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Dec 2009 (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.
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.
The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.
We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.
The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.
The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.
The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| macintosh | Active comparator | Device: macintosh laryngoscope |
| C-MAC | Active comparator | Device: C-MAC laryngoscope |
| Airtraq | Active comparator | Device: Airtraq device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
- Written informed Consent
- No relevant drug allergies
- Patients with 2 or more of the following predictors of difficult intubation:
Key exclusion criteria (2 listed)
- Patients with history of or risk factors for gastric regurgitation
- Patients unable to consent for the trial
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 |
|---|---|---|
| macintosh laryngoscopeintubate with the macintosh laryngoscope | Device | macintosh |
| C-MAC laryngoscopeintubate with the C-MAC laryngoscope | Device | C-MAC |
| Airtraq deviceintubate with the Airtraq device | Device | Airtraq |
Primary outcome
Rate of successful placement of Tube in the Trachea
Time frame: immediately
3 secondary outcomes
1. Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds
Time frame: immediately
2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
Time frame: immediately
3. Laryngeal View Obtained c. Cormac and Lehane Grading of Best Laryngeal View d. Change in view compared to initial assessment by independent anaesthetist. e. POGO score.
Time frame: immediately
Results and safety
The study was stopped early (reason given: Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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 macintosh laryngoscope, C-MAC laryngoscope and Airtraq device in people with Airway and Difficult Intubation, run by University College Hospital Galway at 1 site in Ireland.
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 10 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Jun 2012. 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 Ireland. 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?
The study was stopped early (reason given: Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.). Results are not available in the source record.
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?
Rate of successful placement of Tube in the Trachea (time frame: immediately). 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 19 Jun 2012.