Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2018-04-13

Brief Summary

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In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.

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Detailed Description

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In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.

Conditions

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Intubation Complication Cervical Discopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Videolaryngoscope

Patients intubated with C-Mac D Blade Videolaryngoscope

Group Type ACTIVE_COMPARATOR

C-Mac D Blade

Intervention Type DEVICE

Videolaryngoscope

Fastrach LMA

Patients intubated with Fastrach LMA

Group Type ACTIVE_COMPARATOR

Fastrach LMA

Intervention Type DEVICE

Laryngeal mask airway

Interventions

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C-Mac D Blade

Videolaryngoscope

Intervention Type DEVICE

Fastrach LMA

Laryngeal mask airway

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)
2. American Society of Anesthesiology (ASA) physical status I-III patients

Exclusion Criteria

1. ASA IV patients
2. Age under 18 years, over 70 years
3. Hepatic disease
4. Renal disease
5. Cardiac disease
6. Pregnancy
7. Anticipated difficult airway

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No