NCT03115606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

March 26, 2017

Last Update Submit

May 9, 2018

Conditions

Intubation ComplicationCervical Discopathy

Keywords

videolaryngoscopeFastrach LMAcervical motion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Videolaryngoscope

ACTIVE COMPARATOR

Patients intubated with C-Mac D Blade Videolaryngoscope

Device: C-Mac D Blade

Fastrach LMA

ACTIVE COMPARATOR

Patients intubated with Fastrach LMA

Device: Fastrach LMA

Interventions

C-Mac D BladeDEVICE

Videolaryngoscope

Videolaryngoscope
Fastrach LMADEVICE

Laryngeal mask airway

Fastrach LMA

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, 06810, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 30627738DERIVED

Study Officials

  • derya özkan, assoc prof

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

March 26, 2017

First Posted

April 14, 2017

Study Start

March 24, 2017

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

TU(1)