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OpenTrials
Completed

NCT Number: NCT03115606

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey Ankara, Turkey

Ankara, 06810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA IV patients
  • Age under 18 years, over 70 years
  • Hepatic disease
  • Renal disease
  • Cardiac disease
  • Pregnancy
  • Anticipated difficult airway

Treatment and study plan

C-Mac D Blade

Device

Videolaryngoscope

Fastrach LMA

Device

Laryngeal mask airway

Primary outcomes

  1. Angle A (degree), Angle B (degree), Angle C(degree)

    Time frame: 30 second

    Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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