Clinical trial NCT02033564: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intratracheal Intubation
Laryngoscopes
Postoperative Care
Risk Assessment
Keywords: Sore Throat
Intubation
Laryngoscopy
Anesthesiology
Perioperative
Airway Management
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Albany Medical College
First posted: 2014-01-13
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sore Throat
timeFrame: Within 24 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
Study officials:
affiliation: Department of Anesthesiology, Albany Medical Center
name: Dennis J Cirilla, DO
role: PRINCIPAL_INVESTIGATOR
References:
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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).
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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.