Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy

April 1, 2025 updated by: Cédric Cibotto, University Hospital, Geneva

Assessment of Prehospital Tracheal Intubation Technique Using Initial Direct Laryngoscopy During Videolaryngoscopy: Randomized Controlled Simulated Trial

Tracheal intubation using videolaryngoscopy may be required in the prehospital setting, where airway management presents unique technical and logistical challenges. Intubation may be hard because novice providers performing videolaryngoscopy may only look at the screen and only obtain a two-dimensional representation of the patient's airways. By directly visualizing the airways, these providers may obtain a better 3D apprehension and an improved mental visualization of the patient's anatomy. We aim to compare the impact of a freely realized videolaryngoscopy sequence with a sequence consisting in direct visualization of the airway followed by videolaryngoscopy ("Direct Laryngoscopy-to-VideoLaryngoscopy sequence" or "DL-VL sequence") on time to intubation among novice providers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Hopitaux Universitaires de Geneve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All resident physicians with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM).
  • Performed less than 10 ETIs prior to participating in the study.

Exclusion Criteria:

  • More than 6 years of post-graduate experience
  • Performed more than 10 ETIs prior to participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free use of videolaryngoscopy
Procedure: Free use of videolaryngoscopy
Participants are free to use of the videolaryngoscope as they intended
Experimental: Direct Laryngoscopy-to-VideoLaryngoscopy sequence
Procedure: Direct Laryngoscopy-to-VideoLaryngoscopy sequence
Participants will proceed with a double intubation technique sequence, first performing an initial direct laryngoscopy without looking at the video screen until they reached the epiglottis, then performing an indirect lryngoscopy for intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation
Time Frame: Periprocedural
Time in seconds from blade insertion at the dental arch to adequate tracheal tube placement through the vocal cords, confirmed by the C-MAC video recording. A maximum of 60 seconds was allowed per ETI attempt. The maximum number of ETI attempts was limited to 3.
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation for the first intubation attempt alone
Time Frame: Periprocedural
Time in seconds from blade insertion at the dental arch to adequate tracheal tube placement through the vocal cords, confirmed by the C-MAC video recording. A maximum of 60 seconds was allowed per ETI attempt.
Periprocedural
First Pass Success rate
Time Frame: Periprocedural
Intubation first pass success rate, in percentage.
Periprocedural
Number of intubations attempts
Time Frame: Periprocedural
An ETI attempt was defined as the insertion of the laryngoscope blade at the dental arch, regardless of whether tracheal tube placement was attempted. A maximum of 60 seconds was allowed per ETI attempt. The maximum number of ETI attempts was limited to 3. More than 3 attempts, it was considered as failed.
Periprocedural
Time to Ventilation
Time Frame: Periprocedural
Time in seconds from blade insertion at the dental arch to successful ventilation confirmed by chest elevation. A maximum of 60 seconds was allowed per ETI attempt.
Periprocedural
Subjective assessments
Time Frame: Periprocedural
Subjective assessments, including perceived difficulty (Question 1 - I found intubation easy. Question 2 - I felt comfortable intubating this way. Question 3 - I think the use of the VL was adequate to intubate OR I think the sequenced use of the VL helped me intubate. Question 4 - In a future similar clinical situation, I will make the same use of the VL to intubate OR I think doing a direct laryngoscopy before looking at the screen allows for faster intubation than doing an indirect laryngoscopy only. Question 5 - In a future similar clinical situation, I will make a different use of the VL to intubate OR In a future similar clinical situation, I will make the same use (DL-VL) of the VL to intubate. Question 6 - In a future similar clinical situation, I will make a different use (VL only) of the VL to intubate.), were appraised using a 5-point Likert scale ranging from "Totally Agree" to "Totally Disagree".
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Study Director: PD Dr Laurent Suppan, University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2023

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Req-2023-00073

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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