GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening

GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening, a Prospective Cohort Study

This study aims to evaluate the clinical performance, quality of larynx visualization and difficulty of videolaryngoscopic intubation in patients with a reduced mouth opening (1.0 to 3.0 cm) utilizing the latest generation of GlideScopeTM Spectrum low profile laryngoscopy system.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult; Videolaryngoscopy; Small Mouth

Detailed Description

Reduced mouth opening in adults has been proven an important risk factor for difficult endotracheal intubation utilizing both direct and indirect laryngoscopy techniques, and a major reason for anesthesia-related adverse events. Over the past two decades, videolaryngoscopy has evolved to be the primary indirect laryngoscopy technique in a difficult endotracheal intubation setting. The possibility for optimal visualization of the laryngeal structures renders this method particularly helpful in patients with limited mouth opening. Especially videolaryngoscopy with acute-angle blades has been proposed to be favorable over conventional direct laryngoscopy in this setting. However, previous research has shown that a mouth opening of approximately 2.0 - 3.0 cm represents an independent risk factor and a possible critical lower limit for safe videolaryngoscopic intubation.

The latest generation of GlideScopeTM Spectrum blades may provide sufficient intubation conditions even in patients with a maximum mouth opening below 3.0 cm.

Our research group aims to evaluate the clinical performance, quality of larynx visualization and severity of videolaryngoscopic intubation the GlideScopeTM Spectrum system in patients with a small mouth opening.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for non-cardiac surgery under general anesthesia with a need for endotracheal intubation presenting at the Anesthesiology Preassessment Clinic of the Hamburg University Hospital with a mouth opening between 1.0 and 3.0 cm within the recruiting period.

Description

Inclusion Criteria:

• Patients scheduled for non-cardiac surgery
• Required general anesthesia and endotracheal intubation
• Mouth opening between 1.0 and 3.0 cm (any reason) recognized during preoperative assessment
• Written consent provided

Exclusion Criteria:

• Pregnant or breastfeeding women
• Confirmed indication for awake fiberoptic intubation, especially due to enoral and pharyngeal tumors, abscesses or other obstructive lesions
• Endotracheal intubation planned without deep general anesthesia or without neuromuscular blockade (e.g. awake videolaryngoscopy)
• Qualification for rapid sequence anesthesia induction due to risk of pulmonary aspiration
• Loose teeth

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful videolaryngoscopic endotracheal intubation rate	Observation during airway management	Within 1 hour after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First pass success rate	Observation during airway management	Within 1 hour after anesthesia induction
Endotracheal intubation difficulty	Subjective rating on a numeric rating scale [0-100]; 0 - very easy; 100 - very difficult	Within 1 hour after concluded endotracheal intubation
Best view obtained	Cormack-Lehane classification	Within 1 hour after concluded endotracheal intubation
Intubation time	Observation during airway management	Within 1 hour after anesthesia induction
Number of attempts	Observation during airway management	Within 1 hour after anesthesia induction

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Verathon

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Airway Management; GlideScope; Videolaryngoscopic Intubation
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Microstomia
• Other Study ID Numbers: PV6094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No