LaryngoscopeNCT04087135
Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
A study testing direct laryngoscopy, videolaryngoscopy McGrath and videolaryngoscopy McGrath with suction in people with Laryngoscope and Hemoptysis, run by Université de Montréal at 1 site in Canada.
Trial summary
Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngoscope, Hemoptysis, Simulation
- What is being tested?
- direct laryngoscopy, videolaryngoscopy McGrath and videolaryngoscopy McGrath with suction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 11 Mar 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all wiling doctors and medical residents in the departments of anesthesiology, emergency medicine and intensive care
- experience with the technique of intubation using videolaryngoscopy and direct laryngoscopy.
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Success Rate of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade and a suction advance before the optic of the camera. We hypothesis that, in simulated hemoptysis on the Thiel's embalmed cadaver, the rate of failed intubation at first try will be different depending on the laryngoscope used.
Read the detailed description
For the simulation of hemoptysis, we will need to use the Thiel's embalmed cadaver, who's realism is established, create a synthetic form of blood resembling real blood by its viscosity and color for the simulation and elaborate the dynamic interface of the simulation of hemoptysis. The quantity and way of administration of the blood through the trachea will be tested to obtain a realistic hemoptysis as seen in supraglottic.
For the simulation, we will compare the efficiency of intubation, judged by the failure rate of intubation on first try, for (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade with the suction advanced before the camera. We will also measure the time to intubation, the failure rate of intubation, the suction use and the difficulty of intubation as reported by the participants.
- Conditions
- Laryngoscope, Hemoptysis, Simulation, Cadaver, Intubation; Difficult or Failed
- Being tested
- direct laryngoscopy, videolaryngoscopy McGrath, videolaryngoscopy McGrath with suction
- Keywords
- videolaryngoscopy, Thiel's embalmed cadaver
- Medical subject headings
- Hemoptysis, Cadaver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct laryngoscopyOther
Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.
videolaryngoscopy McGrathOther
Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)
videolaryngoscopy McGrath with suctionOther
Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) and a suction they will advanced directly before the optic of the camera.
| Study group | Role | What they receive |
|---|---|---|
| participant LD | Experimental | Not described Receives: Other: direct laryngoscopy |
| participant VL | Experimental | Not described Receives: Other: videolaryngoscopy McGrath |
| participant VLS | Experimental | Not described Receives: Other: videolaryngoscopy McGrath with suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of intubation on first try
defined as the withdrawal of the laryngoscope from the mouth
Measured: the duration of the simulation
Secondary outcomes (4)
time to intubation
from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff
Measured: the duration of the simulation
failure in intubation
failure to intubate after three try
Measured: the duration of the simulation
use of suction
document the use of suction
Measured: the duration of the simulation
difficulty of intubation
as describe by the participants on a Likert scale 1 to 5
Measured: the duration of the simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start11 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngoscopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each participant will performe the intubation three time using the tools provided, for the same simulation situation: (a) direct laryngoscopy, (b) videolaryngoscopy McGrath and (c) videolaryngoscopy McGrath with suction.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre d'Apprentissage des Habiletés Cliniques (CAAHC), Laboratoire d'anatomie de Trois-Rivières
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087135
- Sponsor's protocol ID
- HP2018
- Status last verified
- Oct 2018
- First submitted
- 9 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Success Rate of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
- ClinicalTrials.gov ID
- NCT04087135
- Acronym / sponsor ID
- HP2018
- Conditions
- Laryngoscope, Hemoptysis, Simulation, Cadaver, Intubation; Difficult or Failed
- Keywords
- videolaryngoscopy, Thiel's embalmed cadaver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre d'Apprentissage des Habiletés Cliniques (CAAHC), Laboratoire d'anatomie de Trois-Rivières
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade and a suction advance before the optic of the camera. We hypothesis that, in simulated hemoptysis on the Thiel's embalmed cadaver, the rate of failed intubation at first try will be different depending on the laryngoscope used.
Detailed description
For the simulation of hemoptysis, we will need to use the Thiel's embalmed cadaver, who's realism is established, create a synthetic form of blood resembling real blood by its viscosity and color for the simulation and elaborate the dynamic interface of the simulation of hemoptysis. The quantity and way of administration of the blood through the trachea will be tested to obtain a realistic hemoptysis as seen in supraglottic.
For the simulation, we will compare the efficiency of intubation, judged by the failure rate of intubation on first try, for (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade with the suction advanced before the camera. We will also measure the time to intubation, the failure rate of intubation, the suction use and the difficulty of intubation as reported by the participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each participant will performe the intubation three time using the tools provided, for the same simulation situation: (a) direct laryngoscopy, (b) videolaryngoscopy McGrath and (c) videolaryngoscopy McGrath with suction.
| Arm | Type | Receives |
|---|---|---|
| participant LD | Experimental | Other: direct laryngoscopy |
| participant VL | Experimental | Other: videolaryngoscopy McGrath |
| participant VLS | Experimental | Other: videolaryngoscopy McGrath with suction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all wiling doctors and medical residents in the departments of anesthesiology, emergency medicine and intensive care
- experience with the technique of intubation using videolaryngoscopy and direct laryngoscopy.
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct laryngoscopyParticipants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade. | Other | participant LD |
| videolaryngoscopy McGrathParticipants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) | Other | participant VL |
| videolaryngoscopy McGrath with suctionParticipants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) and a suction they will advanced directly before the optic of the camera. | Other | participant VLS |
Primary outcome
failure of intubation on first try
Time frame: the duration of the simulation
defined as the withdrawal of the laryngoscope from the mouth
4 secondary outcomes
time to intubation
Time frame: the duration of the simulation
failure in intubation
Time frame: the duration of the simulation
use of suction
Time frame: the duration of the simulation
difficulty of intubation
Time frame: the duration of the simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct laryngoscopy, videolaryngoscopy McGrath and videolaryngoscopy McGrath with suction in people with Laryngoscope and Hemoptysis, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure of intubation on first try (time frame: the duration of the simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.