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Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02382887
Enrollment
40
Registered
2015-03-09
Start date
2009-03-31
Completion date
2017-08-01
Last updated
2018-01-02

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

Conditions

Spinal Injuries

Keywords

intubation, difficult airway, fiberscopy, Airtraq, general anesthesia

Brief summary

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique. However, changes in equipment availability and quality may challenge the fiberoptic intubation technique. The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Detailed description

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique). However, changes in equipment availability and quality may challenge the fiberoptic intubation technique. We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique. Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases: 1. Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements 2. Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed 3. Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices 4. Post Intubation (PI): neuromonitoring after the patient has been intubated 5. Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Interventions

PROCEDUREtracheal intubation

tracheal intubation with the Airtraq

DEVICEAirtraq
DEVICEfiberscope

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* unstable cervical spine due to a cervical vertebra fracture * American Society of Anesthesia classification 1-3 * BMI \< 30 kg/m2 * patients necessitating a general anesthesia for surgery

Exclusion criteria

* patient refusal * ASA \>3 * mouth opening \< 15mm * patients with known history of previous orotracheal tumor surgery

Design outcomes

Primary

MeasureTime frameDescription
Neuromonitoring modifications (modifications appearing on the neuromonitoring)30 secondsmodifications appearing on the neuromonitoring during the 5 different phases

Secondary

MeasureTime frameDescription
time necessary for tracheal intubation180 seconds
tracheal inlet view (best view during intubation)10 secondsbest view during intubation
number of attempts necessary180 seconds

Countries

Switzerland

Outcome results

None listed

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