GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174833
• Other study ID #: PV6094
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: November 17, 2021

Study information

• Verified date: November 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult
• Microstomia
• Small Mouth
• Videolaryngoscopy

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Verathon

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful videolaryngoscopic endotracheal intubation rate	Observation during airway management	Within 1 hour after anesthesia induction
Secondary	First pass success rate	Observation during airway management	Within 1 hour after anesthesia induction
Secondary	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
Secondary	Best view obtained	Cormack-Lehane classification	Within 1 hour after concluded endotracheal intubation
Secondary	Intubation time	Observation during airway management	Within 1 hour after anesthesia induction
Secondary	Number of attempts	Observation during airway management	Within 1 hour after anesthesia induction