Clinical Trial: C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Shikani Optical Scope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury

Brief Summary: 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.

Detailed Summary:

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 a
Sponsor: Lawson Health Research Institute

Current Primary Outcome: cervical spine movement

Original Primary Outcome: Same as current

Current Secondary Outcome: Duration of intubation

Original Secondary Outcome: Same as current

Information By: Lawson Health Research Institute

Dates:
Date Received: April 3, 2006
Date Started: March 2006
Date Completion:
Last Updated: April 12, 2007
Last Verified: September 2006