Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade

NCT ID: NCT02033564

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

Intratracheal Intubation; Laryngoscopes; Postoperative Care; Risk Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Macintosh/Miller Laryngoscope

Macintosh or Miller laryngoscopy blade, preference left up to practitioner conducting intubation. These are the gold standards currently used in laryngoscopy.

Group Type: ACTIVE_COMPARATOR

Macintosh/Miller Laryngoscope

Intervention Type: DEVICE

Glidescope Laryngoscope

Glidescope video-guided laryngoscopy blade

Group Type: ACTIVE_COMPARATOR

Glidescope Laryngoscope

Intervention Type: DEVICE

Interventions

Macintosh/Miller Laryngoscope

Intervention Type: DEVICE

Glidescope Laryngoscope

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Albany Medical College

OTHER

Sponsor Role: collaborator

Jason Ngo, B.S.

OTHER

Sponsor Role: lead

Responsible Party

Jason Ngo, B.S.

Medical Student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dennis J Cirilla, DO

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Albany Medical Center

Locations

Albany Medical Center Hospital

Albany, New York, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 15684262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21150569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21965048 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18635480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20883502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12066737 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 2161310 (View on PubMed)

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).

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15892411 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20574234 (View on PubMed)

Other Identifiers

3215

Identifier Type: -

Identifier Source: org_study_id