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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Cervical Discopathy
• Intervention / Treatment: Device: C-Mac D Blade; Device: Fastrach LMA

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06810
    • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey Ankara, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Videolaryngoscope; Patients intubated with C-Mac D Blade Videolaryngoscope	Device: C-Mac D Blade; Videolaryngoscope
Active Comparator: Fastrach LMA; Patients intubated with Fastrach LMA	Device: Fastrach LMA; Laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: derya özkan, assoc prof, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Anesthesiology and Reanimation Clinic Ankara, Turkey Ankara, Turkey

Publications and helpful links

General Publications

• Ozkan D, Altinsoy S, Sayin M, Dolgun H, Ergil J, Donmez A. Comparison of cervical spine motion during intubation with a C-MAC D-Blade(R) and an LMA Fastrach(R). Anaesthesist. 2019 Feb;68(2):90-96. doi: 10.1007/s00101-018-0533-3. Epub 2019 Jan 9.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: videolaryngoscope; Fastrach LMA; cervical motion
• Other Study ID Numbers: Diskapi3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No