Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade

Sponsor

Jason Ngo, B.S. (Other)

Overall Status

Completed

CT.gov ID

NCT02033564

Collaborator

Albany Medical College (Other)

151

Enrollment

Location

Arms

Duration (Months)

16.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Intratracheal Intubation Laryngoscopes Postoperative Care Risk Assessment	Device: Macintosh/Miller Laryngoscope Device: Glidescope Laryngoscope	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sore Throat [Within 24 hours post-operatively]
Based on subjective yes/no reply by patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.