Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310999
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2006-04-03
Brief Title:
C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Comparison of Shikani Optical Scope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 mgkg propofol and 2-5 mcgkg fentanyl rocuronium 08 mgkg 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
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 patients 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 mgkg propofol and 2-5 mcgkg fentanyl rocuronium 08 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRIC R-05-400 | None | None | None |
| REB 11688 | None | None | None |