C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury - Full Text View

Sponsors and Collaborators:	Lawson Health Research Institute London Health Sciences Centre
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00310999

Purpose

Patients undergoing surgery will have laryngoscopy performed using two widely accepted techniques – Macintosh Laryngoscope and Shikani Optical Scope.

The techniques will be timed and compared for cervical spine movement using fluoroscopy.

Condition	Intervention
Wounds and Injuries	Device: Shikani Optical Stylet

MedlinePlus related topics: Injuries Neck Injuries and Disorders Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Comparison of Shikani Optical Scope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

cervical spine movement

Secondary Outcome Measures:

Duration of intubation

Estimated Enrollment:	24
Study Start Date:	March 2006
Study Completion Date:	June 2006

Detailed Description:

Approval for the study has been obtained from the Review Board for Health and Sciences Research Involving Human Subjects of the University of Western Ontario. Informed and written consent will be obtained from patients who are undergoing elective surgery requiring general anesthesia with endotracheal intubation. Preoperative clinical assessment of the patients will include routine airway evaluation of dentition, mouth opening, tongue size, Mallampati score, and neck mobility.

While awake, the patients will be placed on the operating room table with a rigid board under their head, neck, and torso in order to simulate the table on which patients involved in trauma are placed in the emergency room. In-line stabilization (ILS), as recommended by the ATLS guidelines, will be applied to maintain the patient's head in the neutral position and reduce neck movement during laryngoscopy.

After standard pre-oxygenation, anesthesia will be induced in routine fashion with 2-3 mg/kg propofol and 2-5 mcg/kg fentanyl; rocuronium 0.8 mg/kg will be administered to effect muscle paralysis. The patient will be then be ventilated with sevoflurane in 100% Oxygen via bag and mask for 3 minutes.

After the patient is anesthetized, a sealed envelope containing computer a generated random assignment will be opened. Laryngoscopy will then be performed two times, with the Macintosh laryngoscope and with the Shikani Optical Scope, in random order as determined by the envelope. Between laryngoscopies, the patient will be ventilated with sevoflurane in 100% Oxygen.

For direct Macintosh laryngoscopy, a size 3 laryngoscope blade will be recommended in all patients. With laryngoscopy, the glottis will be exposed to enable positioning of the endotracheal tube at the vocal cords. During the second laryngoscopy in the above sequence, the trachea will be intubated.

The study is then complete. The hard board will be removed and the surgery will proceed in the usual fashion.

The laryngoscopy and intubation will be recorded by a portable fluoroscopy unit for subsequent review by the radiologist to assess relative neck movement.

Laryngoscopy time will be defined as the time from when the laryngoscope blade or Shikani stylet passes the teeth of the patient until the time the endotracheal tube is positioned at the opening of the larynx. If the intubation sequence is longer than 120 seconds, it will be deemed a failure and recorded as such.

The Cormack (11) of the larynx will be recorded for all patients.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Elective non-cardiac surgery patients requiring intubation for the surgery.
Age 18-75
ASA 1-3
Body Mass Index (BMI) < 40

Exclusion Criteria:

patients with previous neck surgery or unstable C-spine
patients with Reflux disease (GERD)
patients who are or may be pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310999

Locations

Canada, Ontario
London Health Sciences Centre University Hospital Site
London, Ontario, Canada, N6A 5A5

Sponsors and Collaborators

Lawson Health Research Institute

London Health Sciences Centre

Investigators

Principal Investigator:	Timothy P Turkstra, MD	London Health Sciences Centre
Principal Investigator:	Rosemary A Craen, MD	London Health Sciences Centre
Principal Investigator:	David M Pelz, MD	London Health Sciences Centre
Principal Investigator:	Allison Shakih, MD	London Health Sciences Centre

More Information

Publications:

Turkstra TP, Craen RA, Pelz DM, Gelb AW. Cervical spine motion: a fluoroscopic comparison during intubation with lighted stylet, GlideScope, and Macintosh laryngoscope. Anesth Analg. 2005 Sep;101(3):910-5, table of contents. Erratum in: Anesth Analg. 2005 Oct;101(4):1011.

Sawin PD, Todd MM, Traynelis VC, Farrell SB, Nader A, Sato Y, Clausen JD, Goel VK. Cervical spine motion with direct laryngoscopy and orotracheal intubation. An in vivo cinefluoroscopic study of subjects without cervical abnormality. Anesthesiology. 1996 Jul;85(1):26-36.

Watts AD, Gelb AW, Bach DB, Pelz DM. Comparison of the Bullard and Macintosh laryngoscopes for endotracheal intubation of patients with a potential cervical spine injury. Anesthesiology. 1997 Dec;87(6):1335-42.

Study ID Numbers:	R-05-400, REB #: 11688, CRIC R-05-400
Study First Received:	April 3, 2006
Last Updated:	April 12, 2007
ClinicalTrials.gov Identifier:	NCT00310999 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

Cervical Vertebrae
Intubation, Intratracheal
Laryngoscopes
Fluoroscopy

Study placed in the following topic categories:

Spinal Injuries
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009