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Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032460
Enrollment
90
Registered
2009-12-15
Start date
2010-01-31
Completion date
2010-11-30
Last updated
2010-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immobilization

Keywords

airway, airway device, cervical spine immobilisation

Brief 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. 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.

Interventions

DEVICEintubate with the Airtraq device

intubate with the Airtraq device

DEVICEintubate with the macintosh laryngoscope

intubate with the macintosh laryngoscope

DEVICEintubate with the C-MAC laryngoscope

intubate with the C-MAC laryngoscope

Sponsors

University College Hospital Galway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* ASA 1 - 3 * Aged 18 - 85 years * Written informed Consent * No relevant drug allergies * Mallampatti 1 - 2.

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frame
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.immediately

Secondary

MeasureTime frame
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.immediatley
Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attemptimmediately
Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO scoreimmediately
Intubation Difficulty Scale scoreimmediately
Need for and number of optimisation Manoeuvres to aid tracheal intubationimmediately

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026