Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade

Postoperative Care Clinical Trial

Official title:

Does the Incidence of Sore Throat Increase With the Use of a Traditional Intubation Blade or the Glidescope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033564
• Other study ID #: 3215
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 9, 2014
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intratracheal Intubation
• Laryngoscopes
• Pharyngitis
• Postoperative Care
• Risk Assessment

Intervention

Device:
• Macintosh/Miller Laryngoscope

• Glidescope Laryngoscope

Locations

Country	Name	City	State
United States	Albany Medical Center Hospital	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Jason Ngo, B.S.	Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View Citation

Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agrò 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. — View 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. — View 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. — View Citation

Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. — View 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. — View 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).

Sharma D. Is GlideScope the best way to intubate? Anesthesiology. 2010 Jul;113(1):258-9; author reply 259. doi: 10.1097/ALN.0b013e3181e0ef5c. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sore Throat	Based on subjective yes/no reply by patient	Within 24 hours post-operatively	Yes