Teach Intubation by Novices in Anaesthesiology

NCT05145556 | Unknown

• 1 other identifier: JohannesGUIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology

Conditions

Learning Problem; Larynx

Keywords

Tracheal Intubation, Learning Technique, Laryngoscope

Outcome Measures

Primary Outcomes (1)

• First pass success rate

  successful tracheal intubation at the first attempt, compared to more than one attempt

  at intubation in 60 seconds

Secondary Outcomes (4)

• Time to ventilation

  at intubation in 120 seconds

• Cormack and Lehane Classification

  at intubation in 120 seconds

• Overall success rate

  at intubation in 120 seconds

• Subjective Training Process

  at one month

Study Arms (2)

Videolaryngoscopy (McGrath Macintosh)

EXPERIMENTAL

First pass success rate using the videolaryngoscopy

Device: Videolarygoscopy

conventional direct laryngoscopy

EXPERIMENTAL

First pass success rate using the conventional direct laryngoscopy

Device: conventional laryngoscopy

Interventions

Videolarygoscopy DEVICE

In a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea.

Videolaryngoscopy (McGrath Macintosh)

conventional laryngoscopy DEVICE

In a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

conventional direct laryngoscopy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 Years
• capacity to consent
• Present written informed consent of the research participant

You may not qualify if:

• Age \<18 years
• Lack of consent
• inability to consent

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

RECRUITING

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marc MK Kriege, PD Dr

  University JG, Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc MK Kriege, PD Dr

CONTACT

00496131170; MaKriege@uni-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Starting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubations

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 6, 2021
• Study Start: December 2, 2021
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)