A.I. Supported Laryngoscopy and Endotracheal Intubation: a Manikin Study

NCT06657417 | Completed DMC

• 1 other identifier: ANEST-0004
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

LarynGuide is a newly developed AI-supported software for video laryngoscopy that supports the user through correct placement of endotracheal tube by means of audio-visual signals and warning of incorrect or potentially dangerous handling. This prospective study assesses the performance of tracheal intubation using video laryngoscopy with larynGuide AI overlay as compared to standard video larnygoscopy an simulation setting.

Conditions

Intubation; Difficult or Failed

Keywords

Tracheal intubation; airway management; C-MAC video laryngoscope; LarynGuide software

Outcome Measures

Primary Outcomes (1)

• Rate of first-attempt tracheal intubation success

  12 single attempts per participant

  2 minutes

Secondary Outcomes (4)

• Time to intubation

  2 minutes

• Rate of total intubation success

  2 minutes

• Global Rating Scale of Procedural Performance

  2 minutes

• Percentage of dental damage incidence

  2 minutes

Study Arms (2)

Standard before AI support

EXPERIMENTAL

Device: Video laryngoscopy

AI support before standard

EXPERIMENTAL

Device: Video larnygoscopy

Interventions

Video laryngoscopy DEVICE

Standard video laryngoscopy before video laryngoscopy with additional larynGuide overlay

Standard before AI support

Video larnygoscopy DEVICE

Video laryngoscopy with additional larynGuide overlay before standard video laryngoscopy

AI support before standard

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1. Volunteer medical professionals 2. Experienced: consultant anaesthetists, resident anaesthetists and certified nurse 3. Inexperienced: junior doctors (other than anaesthetists), clinical year medical students, nurses and paramedics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Study Officials

• Christoph K Hofer, MD

  Schulthess Klinik

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is a randomized 2x2 crossover design. Each procedure will be performed by the same participant in sequence with at least 3 days between the first and second round of procedures. The procedures will be performed in sequence to which the participants were randomized (TC: First Test and then Control or CT: First Control and then Test). A sequence of 6 intubations will be performed in each sitting (in order, 3 easy and 3 difficult).

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 24, 2024
• Study Start: March 1, 2024
• Primary Completion: August 25, 2024
• Study Completion: August 30, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)