Indication of Orotracheal IntubationPhase 3AMACNCT04930419
Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
A Phase 3 study testing Videolaryngoscopy group and Direct laryngoscopy group in people with Indication of Orotracheal Intubation and Cardio Respiratory Arrest, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients. To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication of Orotracheal Intubation, Cardio Respiratory Arrest, Respiratory Failure
- What is being tested?
- Videolaryngoscopy group and Direct laryngoscopy group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 15 Dec 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- Indication of orotracheal intubation
- Operators trained to the use of the McGrath
Who cannot join
- Pregnancy
- No insurance
- Major patient under guardianship or curatorship
Trial locations and contacts
No sites are listed yet.
About this study
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.
To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.
Read more
As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.
Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.
Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.
Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.
Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.
The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.
The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.
Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
- Conditions
- Indication of Orotracheal Intubation, Cardio Respiratory Arrest, Respiratory Failure, Neurological Failure
- Being tested
- Videolaryngoscopy group, Direct laryngoscopy group
- Medical subject headings
- Heart Arrest, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscopy groupDevice
Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
Direct laryngoscopy groupDevice
Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention. and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy group | Other | Not described Receives: Device: Videolaryngoscopy group |
| Direct laryngoscopy group | Other | Not described Receives: Device: Direct laryngoscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful intubation at the first attempt
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
Measured: up to 10 minutes post inclusion
Secondary outcomes (11)
Number of attempts needed for successful intubation
Measured: up to 10 minutes post inclusion
Time to intubate
Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
Measured: up to 10 minutes post inclusion
Reason of failure of the first-pass success
Reasons of failure will be defined as following :
- Bad glottic visualization
- Difficult progression of the tube towards the glottis despite a good visualisation
- Presence of secretions
- Presence of foreign body
- Presence of fogging on the McGrath
- Device failure
- Other
Measured: up to 10 minutes post inclusion
Proportion of decision of switch in case of failure
Measured: up to 10 minutes post inclusion
Proportion of difficult intubations
Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ). It goes from 0 to infinity. zero indicating an easy intubation and infinity being an impossible intubation
Measured: up to 10 minutes post inclusion
Glottic view
Glottic view will be evaluated with Cormack and Lehane grade and POGO score. POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis). Cormack and Lehane grade goes from I to IV. A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
Measured: up to 10 minutes post inclusion
Proportion of cases who need for tools to optimize
Measured: up to 10 minutes post inclusion
Proportion of cases needed crossovers to other rescue techniques
Measured: up to 10 minutes post inclusion
Number of complications per and post-intubation
Measured: up to 10 minutes post inclusion
Type of complications per and post-intubation
Measured: up to 10 minutes post inclusion
Number of deaths
Measured: up to 10 minutes post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication of Orotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930419
- Sponsor's protocol ID
- K170405J
- Acronym
- AMAC
- Status last verified
- May 2021
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT04930419
- Acronym / sponsor ID
- AMAC / K170405J
- Conditions
- Indication of Orotracheal Intubation, Cardio Respiratory Arrest, Respiratory Failure, Neurological Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 18 Jun 2021 (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.
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.
To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.
As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.
Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.
Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.
Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.
Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.
The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.
The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.
Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy group | Other | Device: Videolaryngoscopy group |
| Direct laryngoscopy group | Other | Device: Direct laryngoscopy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18
- Indication of orotracheal intubation
- Operators trained to the use of the McGrath
Key exclusion criteria (3 listed)
- Pregnancy
- No insurance
- Major patient under guardianship or curatorship
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 |
|---|---|---|
| Videolaryngoscopy groupTracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care | Device | Videolaryngoscopy group |
| Direct laryngoscopy groupTracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention. and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care | Device | Direct laryngoscopy group |
Primary outcome
Rate of successful intubation at the first attempt
Time frame: up to 10 minutes post inclusion
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
11 secondary outcomes
Number of attempts needed for successful intubation
Time frame: up to 10 minutes post inclusion
Time to intubate
Time frame: up to 10 minutes post inclusion
Reason of failure of the first-pass success
Time frame: up to 10 minutes post inclusion
Proportion of decision of switch in case of failure
Time frame: up to 10 minutes post inclusion
Proportion of difficult intubations
Time frame: up to 10 minutes post inclusion
Glottic view
Time frame: up to 10 minutes post inclusion
Proportion of cases who need for tools to optimize
Time frame: up to 10 minutes post inclusion
Proportion of cases needed crossovers to other rescue techniques
Time frame: up to 10 minutes post inclusion
Number of complications per and post-intubation
Time frame: up to 10 minutes post inclusion
Type of complications per and post-intubation
Time frame: up to 10 minutes post inclusion
Number of deaths
Time frame: up to 10 minutes post inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Videolaryngoscopy group and Direct laryngoscopy group in people with Indication of Orotracheal Intubation and Cardio Respiratory Arrest, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baudoin Clémence (+331 49 95 61 61, clemence.baudoin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful intubation at the first attempt (time frame: up to 10 minutes post inclusion). 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 18 Jun 2021.