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

D

Diskapi Teaching and Research Hospital

Status

Completed

Conditions

Cervical Discopathy
Intubation Complication

Treatments

Device: Fastrach LMA
Device: C-Mac D Blade

Study type

Interventional

Funder types

Other

Identifiers

NCT03115606
Diskapi3

Details and patient eligibility

About

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.

Full description

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.

Enrollment

52 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Videolaryngoscope
Active Comparator group
Description:
Patients intubated with C-Mac D Blade Videolaryngoscope
Treatment:
Device: C-Mac D Blade
Fastrach LMA
Active Comparator group
Description:
Patients intubated with Fastrach LMA
Treatment:
Device: Fastrach LMA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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