King Vision and Cervical Spines Movement

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Dammam University
Sponsor:
Information provided by (Responsible Party):
Dammam University
ClinicalTrials.gov Identifier:
NCT01914601
First received: July 28, 2013
Last updated: June 28, 2014
Last verified: June 2014
  Purpose

Extensive cervical spines movement during endotracheal intubation can result in serious neurological injury, especially in the patients with unrecognized cervical spines injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited because of arthritis, disc disease or a small gap between the occiput and the spinous process of the atlas.[3-4]

Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and tracheal axes which minimize the cervical movements, especially in the patients with restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of AirWay Scope decreases median upper cervical-spine movement during intubation under in-line stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video laryngoscopes are associated with longer times to tracheal intubation compared with the traditional techniques which may be attributed to the variable learning curves of the practitioners. [7-9]

The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses fiberoptic technology to view the larynx with micro camera offers a 160 degree of view potentially eliminating the need for neck flexion and head extension. [10]

To the best of the authors' knowledge, there is no study has evaluated the King vision laryngoscope regarding the neck movement during routine tracheal intubation under general anesthesia.


Condition Intervention Phase
Need Tracheal Intubation
Device: Macintosh-King Vision
Device: King Vision-Macintosh
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Does King Vision® Videolaryngoscope Reduce Cervical Spine Motion During Endotracheal Intubation? A Cross-over Study.

Resource links provided by NLM:


Further study details as provided by Dammam University:

Primary Outcome Measures:
  • cervical spine movement [ Time Frame: Participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds ] [ Designated as safety issue: Yes ]
    cervical spine movement during tracheal intubation


Secondary Outcome Measures:
  • time to intubation [ Time Frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds ] [ Designated as safety issue: Yes ]
    the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis

  • laryngoscopic view [ Time Frame: participants will be followed for the duration of laryngoscopy, an expected average of 90 seconds ] [ Designated as safety issue: No ]
    The glottic view during laryngoscopy will be assessed according to the Cormack-Lehane grading system: Grade 1, full view; Grade 2, only arytenoid cartilages visible; Grade 3, only epiglottis visible; and Grade 4, epiglottis not visible

  • ease of intubation [ Time Frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds ] [ Designated as safety issue: Yes ]
    rate the ease of intubation using a 100 mm visual analog scale (0 for much of ease and 100 for extremely difficult).

  • number of intubation attempts [ Time Frame: participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds ] [ Designated as safety issue: Yes ]
  • number of optimization maneuvers [ Time Frame: participants will be followed for the duration of laryngoscopy, an expected average of 90 seconds ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Macintosh-King Vision
laryngoscopy will be performed with the Macintosh followed by the King Vision laryngoscope
Device: Macintosh-King Vision
laryngoscopy will be performed with the Macintosh followed by the King Vision laryngoscope
Active Comparator: King Vision-Macintosh
laryngoscopy will be performed with the King Vision followed by the Macintosh laryngoscope.
Device: King Vision-Macintosh
laryngoscopy will be performed with the King Vision followed by the Macintosh laryngoscope.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sixteen American Society of Anesthesiologists physical status class I-II
  • aged 18-65 years
  • scheduled for elective minor surgery
  • under general anesthesia

Exclusion Criteria:

  • predicted or known difficult airway
  • history of cervical spine injury
  • history of cervical spine surgery
  • previous oral surgery
  • previous throat surgery
  • previous neck surgery
  • gastro-esophageal reflux disease
  • need for rapid sequence induction
  • emergent surgery
  • pregnancy
  • body mass index higher than 35 kg/m2
  • without incisor teeth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914601

Contacts
Contact: Mohamed R El Tahan, MD +966569371849 mohamedrefaateltahan@yahoo.com
Contact: Abdulmohsen Al Ghamdi, MD +966505814737 mohsenkfu@hotmail.com

Locations
Saudi Arabia
King Fahd Hospital of the University Not yet recruiting
Al Khubar, Eastern, Saudi Arabia, 31952
Contact: Abdulmohsen Al Ghamdi, MD    +966505814737    mohsenkfu@hotmail.com   
King Fahd Hospital of Dammam University Recruiting
Al Khubar, Eastern, Saudi Arabia, 31592
Contact: Mohamed R El Tahan, MD    +966138966666 ext 2022    meltahan@ud.edu.sa   
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Abdulmohsen Al Ghamdi, MD Associate Professor/Chairman of Anesthesiology
Study Director: Mohamed R El Tahan, MD Associate Professor of Anesthesiology
Study Chair: Alaa M Khidr, MD Assistant Professor of Anesthesiology
Study Chair: Abdullah s Al Mulhim, MD Demonstrator of Radiology
  More Information

No publications provided

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT01914601     History of Changes
Other Study ID Numbers: KFHU-FBR 0040
Study First Received: July 28, 2013
Last Updated: June 28, 2014
Health Authority: Saudi Arabia: Ministry of Higher Education

Keywords provided by Dammam University:
Laryngoscope
Macintosh
King Vision
tracheal intubation
cervical spines

ClinicalTrials.gov processed this record on August 21, 2014