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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings