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

Not Applicable

Completed

• Conditions: Cervical Discopathy; Intubation Complication
• Interventions: Device: Fastrach LMA; Device: C-Mac D Blade

• Registration Number: NCT03115606
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-03-24
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2018-04-13
• Study Completion: 2018-04-13
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fastrach LMA	Fastrach LMA	Patients intubated with Fastrach LMA
Videolaryngoscope	C-Mac D Blade	Patients intubated with C-Mac D Blade Videolaryngoscope

Primary Outcome Measures

Name	Time	Method
Angle A (degree), Angle B (degree), Angle C(degree)	30 second	Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)

Trial Locations

Locations (1)

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