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

Primary Purpose

Wounds and Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Shikani Optical Stylet
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Cervical Vertebrae, Intubation, Intratracheal, Laryngoscopes, Fluoroscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London Health Sciences Centre University Hospital Site

Outcomes

Primary Outcome Measures

cervical spine movement

Secondary Outcome Measures

Duration of intubation

Full Information

First Posted
April 3, 2006
Last Updated
November 2, 2018
Sponsor
Lawson Health Research Institute
Collaborators
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00310999
Brief Title
C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury
Official Title
Comparison of Shikani Optical Scope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
London Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Cervical Vertebrae, Intubation, Intratracheal, Laryngoscopes, Fluoroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Shikani Optical Stylet
Primary Outcome Measure Information:
Title
cervical spine movement
Secondary Outcome Measure Information:
Title
Duration of intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy P Turkstra, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosemary A Craen, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M Pelz, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison Shakih, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre University Hospital Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16116013
Citation
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):910-915. doi: 10.1213/01.ane.0000166975.38649.27. Erratum In: Anesth Analg. 2005 Oct;101(4):1011.
Results Reference
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PubMed Identifier
8694378
Citation
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. doi: 10.1097/00000542-199607000-00005.
Results Reference
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PubMed Identifier
9416718
Citation
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. doi: 10.1097/00000542-199712000-00012.
Results Reference
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C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury

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