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Completed

NCT Number: NCT04174833

GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Successful videolaryngoscopic endotracheal intubation rate

    Time frame: Within 1 hour after anesthesia induction

    Observation during airway management

Secondary outcomes

  1. First pass success rate

    Time frame: Within 1 hour after anesthesia induction

    Observation during airway management

  2. Endotracheal intubation difficulty

    Time frame: Within 1 hour after concluded endotracheal intubation

    Subjective rating on a numeric rating scale [0-100]; 0 - very easy; 100 - very difficult

  3. Best view obtained

    Time frame: Within 1 hour after concluded endotracheal intubation

    Cormack-Lehane classification

  4. Intubation time

    Time frame: Within 1 hour after anesthesia induction

    Observation during airway management

  5. Number of attempts

    Time frame: Within 1 hour after anesthesia induction

    Observation during airway management

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Verathon

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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