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

NCT ID: NCT02382887

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-08-01

Brief Summary

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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

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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

Conditions

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Spinal Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tracheal intubation with Fiberscopy

tracheal intubation with a fiberscope

Group Type ACTIVE_COMPARATOR

tracheal intubation

Intervention Type PROCEDURE

tracheal intubation with the Airtraq

fiberscope

Intervention Type DEVICE

Tracheal intubation with Airtraq

tracheal intubation with an Airtraq

Group Type EXPERIMENTAL

tracheal intubation

Intervention Type PROCEDURE

tracheal intubation with the Airtraq

Airtraq

Intervention Type DEVICE

Interventions

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tracheal intubation

tracheal intubation with the Airtraq

Intervention Type PROCEDURE

Airtraq

Intervention Type DEVICE

fiberscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Patrick Schoettker,MD PD

MD, PD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Schoettker, MD, PD

Role: PRINCIPAL_INVESTIGATOR

Chief Medical Officer

Locations

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Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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225/08

Identifier Type: -

Identifier Source: org_study_id

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