Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade
Primary Purpose
Intratracheal Intubation, Laryngoscopes, Postoperative Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Macintosh/Miller Laryngoscope
Glidescope Laryngoscope
Sponsored by
About this trial
This is an interventional treatment trial for Intratracheal Intubation focused on measuring Sore Throat, Intubation, Laryngoscopy, Anesthesiology, Perioperative, Airway Management
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 18 - 80 years old.
- Able to provide written informed consent and to comply with all study procedures
- Scheduled for elective inpatient or outpatient surgery requiring general anesthesia and orotracheal intubation.
Exclusion Criteria:
- Known difficult airway based on prior medical history
- American Society of Anesthesiologists physical status score > IV
- Presence of abnormal cervical spine movement (normal > 90°)
- Airway Mallampati score ≥ III
- Thyromental distance ≥ 6
- Upper lip bite test ≥ 3
- Degree of retrognathia
- Previous medical history indicating patient has a known difficult airway
- Judgment that patient will require intubation post-operatively
- Are emergency surgery cases
- Are Ear-Nose-Throat (ENT) or neck surgery cases
- Have a planned post-operative ICU stay
- Inadequate Nil Per Os (NPO) status prior to surgical case
- Prisoner status
Sites / Locations
- Albany Medical Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Macintosh/Miller Laryngoscope
Glidescope Laryngoscope
Arm Description
Macintosh or Miller laryngoscopy blade, preference left up to practitioner conducting intubation. These are the gold standards currently used in laryngoscopy.
Glidescope video-guided laryngoscopy blade
Outcomes
Primary Outcome Measures
Sore Throat
Based on subjective yes/no reply by patient
Secondary Outcome Measures
Full Information
NCT ID
NCT02033564
First Posted
January 8, 2014
Last Updated
January 9, 2014
Sponsor
Jason Ngo, B.S.
Collaborators
Albany Medical College
1. Study Identification
Unique Protocol Identification Number
NCT02033564
Brief Title
Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade
Official Title
Does the Incidence of Sore Throat Increase With the Use of a Traditional Intubation Blade or the Glidescope
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Ngo, B.S.
Collaborators
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose in this study is to determine whether there is a difference in the incidence of postoperative sore throat when using the GlideScope™ versus a traditional intubation blade involving patients that are not anticipated to have a difficult airway.
Detailed Description
The goal of this study is to determine whether the use of the GlideScope™ video laryngoscope during intubation leads to a greater or lesser incidence of sore throat when compared to traditional laryngoscope blades used for intubation, such as the Macintosh or Miller blade. During postoperative checks by a board certified anesthesiologist at the Albany Medical Center (AMC) Hospital, it was noticed that patients who reported sore throat often required intubation with the GlideScope™. Standard of care at the AMC Hospital dictates that the Glidescope is used as a "rescue" device for failed direct laryngoscopy on a difficult airway; if traditional direct laryngoscopy with a Macintosh or Miller blade cannot provide adequate laryngeal views, progression to a different airway device such as the Glidescope or fiberoptic scope is indicated. The initial attempt with direct laryngoscopy on a difficult airway often requires utilization of McGill forceps, which increases the chance of upper airway injury prior to the rescue attempt with the GlideScope. Consequently, it is difficult to determine whether patients' reports of post-operative sore throat are caused by the irritation inflicted by the multiple laryngoscopic attempts required in patients where the Glidescope was needed as a rescue method, or whether it is due to the actual utilization of the Glidescope itself.
Previous studies have shown that the use of a GlideScope™ decreases the likelihood of upper airway injury by decreasing the lower mean force applied during laryngoscopy when compared to a Macintosh laryngoscope; however, this study was done using manikins and it is not known whether this result can be translated to a patient oriented outcome. Another study compared the GlideScope™ to direct laryngoscopy for nasotracheal intubation. Their results suggested that the incidence of postoperative moderate or severe sore throat was significantly reduced with use of the GlideScope™ videolaryngoscope. However, other studies have shown increased incidence of postoperative sore throat with Glidescope usage when compared to other videolaryngoscopes and conventional Macintosh laryngoscope as a primary laryngoscopy method. In light of these studies, none have attempted a direct comparison of a Glidescope with conventional Macintosh/Miller laryngoscope blades with incidence of sore throat as a primary outcome of interest.
The purpose in this study is to determine whether there is a difference in the incidence of postoperative sore throat when using the GlideScope™ versus a traditional intubation blade involving patients that are not anticipated to have a difficult airway. Exclusion of patients with difficult airways allows us to perform direct comparisons with the Glidescope and conventional direct laryngoscopy without compromising standard of care or increasing patient risk, which will be determined by the use of standard of care preoperative exams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intratracheal Intubation, Laryngoscopes, Postoperative Care, Risk Assessment
Keywords
Sore Throat, Intubation, Laryngoscopy, Anesthesiology, Perioperative, Airway Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macintosh/Miller Laryngoscope
Arm Type
Active Comparator
Arm Description
Macintosh or Miller laryngoscopy blade, preference left up to practitioner conducting intubation. These are the gold standards currently used in laryngoscopy.
Arm Title
Glidescope Laryngoscope
Arm Type
Active Comparator
Arm Description
Glidescope video-guided laryngoscopy blade
Intervention Type
Device
Intervention Name(s)
Macintosh/Miller Laryngoscope
Intervention Type
Device
Intervention Name(s)
Glidescope Laryngoscope
Primary Outcome Measure Information:
Title
Sore Throat
Description
Based on subjective yes/no reply by patient
Time Frame
Within 24 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 18 - 80 years old.
Able to provide written informed consent and to comply with all study procedures
Scheduled for elective inpatient or outpatient surgery requiring general anesthesia and orotracheal intubation.
Exclusion Criteria:
Known difficult airway based on prior medical history
American Society of Anesthesiologists physical status score > IV
Presence of abnormal cervical spine movement (normal > 90°)
Airway Mallampati score ≥ III
Thyromental distance ≥ 6
Upper lip bite test ≥ 3
Degree of retrognathia
Previous medical history indicating patient has a known difficult airway
Judgment that patient will require intubation post-operatively
Are emergency surgery cases
Are Ear-Nose-Throat (ENT) or neck surgery cases
Have a planned post-operative ICU stay
Inadequate Nil Per Os (NPO) status prior to surgical case
Prisoner status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis J Cirilla, DO
Organizational Affiliation
Department of Anesthesiology, Albany Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15684262
Citation
Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.
Results Reference
background
PubMed Identifier
21150569
Citation
Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
Results Reference
background
PubMed Identifier
21965048
Citation
Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agro FE. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal and difficult airways: a manikin study. Br J Anaesth. 2012 Jan;108(1):146-51. doi: 10.1093/bja/aer304. Epub 2011 Sep 28.
Results Reference
background
PubMed Identifier
18635480
Citation
Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9.
Results Reference
background
PubMed Identifier
20883502
Citation
Teoh WH, Saxena S, Shah MK, Sia AT. Comparison of three videolaryngoscopes: Pentax Airway Scope, C-MAC, Glidescope vs the Macintosh laryngoscope for tracheal intubation. Anaesthesia. 2010 Nov;65(11):1126-32. doi: 10.1111/j.1365-2044.2010.06513.x. Epub 2010 Sep 30.
Results Reference
background
PubMed Identifier
12066737
Citation
Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
Results Reference
background
PubMed Identifier
2161310
Citation
Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
Results Reference
background
Citation
Krasser K, Missaghi-Berlini S M, Moser A, Zadrobilek E. Evaluation of the standard adult GlideScope videolaryngoscope: orotracheal intubation performed by novice users after formal instruction. Internet Journal of Airway Management. Available from URL; http://www.ijam.at/volume03/clinicalinvestigation01/default.htm (accessed July 25, 2013).
Results Reference
background
PubMed Identifier
15892411
Citation
Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur J Anaesthesiol. 2005 Apr;22(4):307-11. doi: 10.1017/s0265021505000529.
Results Reference
background
PubMed Identifier
20574234
Citation
Sharma D. Is GlideScope the best way to intubate? Anesthesiology. 2010 Jul;113(1):258-9; author reply 259. doi: 10.1097/ALN.0b013e3181e0ef5c. No abstract available.
Results Reference
background
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Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade
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