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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115606
• Other study ID #: Diskapi3
• Status: Completed
• Phase: N/A
• Start date: March 24, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: May 2018
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Discopathy
• Intubation Complication

Intervention

Device:
• C-Mac D Blade
Videolaryngoscope
• Fastrach LMA
Laryngeal mask airway

Locations

Country	Name	City	State
Turkey	Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital Ankara, Turkey Ankara, Turkey	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angle A (degree), Angle B (degree), Angle C(degree)	Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)	30 second

External Links

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