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Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade

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ClinicalTrials.gov Identifier: NCT02033564
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Jason Ngo, B.S., Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Intratracheal Intubation Laryngoscopes Postoperative Care Risk Assessment Device: Macintosh/Miller Laryngoscope Device: Glidescope Laryngoscope Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does the Incidence of Sore Throat Increase With the Use of a Traditional Intubation Blade or the Glidescope
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Active Comparator: Macintosh/Miller Laryngoscope
Macintosh or Miller laryngoscopy blade, preference left up to practitioner conducting intubation. These are the gold standards currently used in laryngoscopy.
Device: Macintosh/Miller Laryngoscope
Active Comparator: Glidescope Laryngoscope
Glidescope video-guided laryngoscopy blade
Device: Glidescope Laryngoscope



Primary Outcome Measures :
  1. Sore Throat [ Time Frame: Within 24 hours post-operatively ]
    Based on subjective yes/no reply by patient



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033564


Locations
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United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Sponsors and Collaborators
Jason Ngo, B.S.
Albany Medical College
Investigators
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Principal Investigator: Dennis J Cirilla, DO Department of Anesthesiology, Albany Medical Center

Publications:
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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Responsible Party: Jason Ngo, B.S., Medical Student, Albany Medical College
ClinicalTrials.gov Identifier: NCT02033564     History of Changes
Other Study ID Numbers: 3215
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Jason Ngo, B.S., Albany Medical College:
Sore Throat
Intubation
Laryngoscopy
Anesthesiology
Perioperative
Airway Management
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases