Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade

NCT02033564 | Completed

• 1 other identifier: 3215
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Intratracheal Intubation; Laryngoscopes; Postoperative Care; Risk Assessment

Keywords

Sore Throat; Intubation; Laryngoscopy; Anesthesiology; Perioperative; Airway Management

Outcome Measures

Primary Outcomes (1)

• Sore Throat

  Based on subjective yes/no reply by patient

  Within 24 hours post-operatively

Study Arms (2)

Macintosh/Miller Laryngoscope

ACTIVE COMPARATOR

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

Glidescope Laryngoscope

ACTIVE COMPARATOR

Glidescope video-guided laryngoscopy blade

Device: Glidescope Laryngoscope

Interventions

Macintosh/Miller Laryngoscope DEVICE

Macintosh/Miller Laryngoscope

Glidescope Laryngoscope DEVICE

Glidescope Laryngoscope

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Ngo, B.S.: lead
• Albany Medical College: collaborator

Study Sites (1)

Albany Medical Center Hospital

Albany, New York, 12208, United States

Location

Related Publications (10)

• 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. doi: 10.1007/BF03027728.

  PMID: 15684262 BACKGROUND

• 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.

  PMID: 21150569 BACKGROUND

• 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.

  PMID: 21965048 BACKGROUND

• 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.

  PMID: 18635480 BACKGROUND

• 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.

  PMID: 20883502 BACKGROUND

• 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.

  PMID: 12066737 BACKGROUND

• Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.

  PMID: 2161310 BACKGROUND

• 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).

  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.

  PMID: 15892411 BACKGROUND

• 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.

  PMID: 20574234 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dennis J Cirilla, DO

  Department of Anesthesiology, Albany Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 13, 2014
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)