ImmobilizationNCT01032460
Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
A study testing intubate with the macintosh laryngoscope, intubate with the C-MAC laryngoscope and intubate with the Airtraq device in people with Immobilization, 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 the neck is immobilized. The Airtraq® Laryngoscope and the CMAC are new intubating devices. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Immobilization
- What is being tested?
- intubate with the macintosh laryngoscope, intubate with the C-MAC laryngoscope and intubate with the Airtraq device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2010to Nov 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 - 3
- Aged 18 - 85 years
- Written informed Consent
- No relevant drug allergies
- Mallampatti 1 - 2.
Who cannot join
- Patients unable to cooperate with airway assessment (2)
- Patients with predicted difficult intubation
- Mallampatti III or IV
- Thyromental distance < 6cm
- Mouth opening < 3.5 cm
- Cervical spine disease
Show all 11Show fewer
- Anteriorly protruding incisors
- Poor Dentition (2)
- Tumours, polyps or foreign bodies in the upper airway (2)
- Patients with documented difficult airways (2).
- Patients with history of or risk factors for gastric regurgitation (i.e. require rapid sequence induction of anaesthesia)
Trial locations and contacts
1 site in 1 country.
About this study
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized.
The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
Read more
These devices may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.
The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.
Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.
- Conditions
- Immobilization
- Being tested
- intubate with the macintosh laryngoscope, intubate with the C-MAC laryngoscope, intubate with the Airtraq device
- Keywords
- airway, airway device, cervical spine immobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubate with the macintosh laryngoscopeDevice
intubate with the macintosh laryngoscope
intubate with the C-MAC laryngoscopeDevice
intubate with the C-MAC laryngoscope
intubate with the Airtraq deviceDevice
intubate with the Airtraq device
| Study group | Role | What they receive |
|---|---|---|
| macintosh | Active comparator | Not described Receives: Device: intubate with the macintosh laryngoscope |
| C-MAC | Active comparator | Not described Receives: Device: intubate with the C-MAC laryngoscope |
| Airtraq | Active comparator | Not described Receives: Device: intubate with the 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 a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.
Measured: immediately
Secondary outcomes (5)
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: immediatley
Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
Measured: immediately
Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score
Measured: immediately
Intubation Difficulty Scale score
Measured: immediately
Need for and number of optimisation Manoeuvres to aid tracheal intubation
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 completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmobilizationStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032460
- Sponsor's protocol ID
- CMAC-3
- Status last verified
- Jul 2010
- First submitted
- 14 Dec 2009
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
- ClinicalTrials.gov ID
- NCT01032460
- Acronym / sponsor ID
- CMAC-3
- Conditions
- Immobilization
- Keywords
- airway, airway device, cervical spine immobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (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 the neck is immobilized.
The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
These devices may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.
The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.
Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.
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: intubate with the macintosh laryngoscope |
| C-MAC | Active comparator | Device: intubate with the C-MAC laryngoscope |
| Airtraq | Active comparator | Device: intubate with the Airtraq device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA 1 - 3
- Aged 18 - 85 years
- Written informed Consent
- No relevant drug allergies
- Mallampatti 1 - 2.
Key exclusion criteria (11 listed)
- Patients unable to cooperate with airway assessment (2)
- Patients with predicted difficult intubation
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 |
|---|---|---|
| intubate with the macintosh laryngoscopeintubate with the macintosh laryngoscope | Device | macintosh |
| intubate with the C-MAC laryngoscopeintubate with the C-MAC laryngoscope | Device | C-MAC |
| intubate with the Airtraq deviceintubate with the Airtraq device | Device | Airtraq |
Primary outcome
Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.
Time frame: immediately
5 secondary outcomes
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: immediatley
Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
Time frame: immediately
Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score
Time frame: immediately
Intubation Difficulty Scale score
Time frame: immediately
Need for and number of optimisation Manoeuvres to aid tracheal intubation
Time frame: immediately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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 intubate with the macintosh laryngoscope, intubate with the C-MAC laryngoscope and intubate with the Airtraq device in people with Immobilization, 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 5 inclusion and 11 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 9 Nov 2010. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator. (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 9 Nov 2010.