GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening

NCT04174833 | Completed

• 1 other identifier: PV6094
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation;Difficult; Videolaryngoscopy; Small Mouth

Keywords

GlideScope; Airway Management; Videolaryngoscopic Intubation

Outcome Measures

Primary Outcomes (1)

• Successful videolaryngoscopic endotracheal intubation rate

  Observation during airway management

  Within 1 hour after anesthesia induction

Secondary Outcomes (5)

• First pass success rate

  Within 1 hour after anesthesia induction

• Endotracheal intubation difficulty

  Within 1 hour after concluded endotracheal intubation

• Best view obtained

  Within 1 hour after concluded endotracheal intubation

• Intubation time

  Within 1 hour after anesthesia induction

• Number of attempts

  Within 1 hour after anesthesia induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Verathon: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Microstomia

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: November 22, 2019
• Study Start: January 20, 2021
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

DE (1)