Intubation; Difficult or FailedNCT05303948
Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness
A study testing Videolaryngoscopy / Direct Laryngoscopy in people with Intubation; Difficult or Failed and Intubation Complication, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
Trial summary
In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- Videolaryngoscopy / Direct Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 18 Oct 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- aged between 18 and 65 years old.
- Absence of pregnancy
- Belonging to a Health Insurance Coverage by the French Social Security Program or equivalent, proved by a European Health Insurance Card (EHIC).
- Medically fit to fly after a JAR FCL3 - Class 2 examination
Who cannot join
- positive pregnancy test on flight day
- anxiety
- non-participation in flight safety briefing
- failure to follow safety guidelines
- occurence of motion sickness during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Comparison of Two Positions for Free Floating Tracheal Intubation in Weightlessness: An Ice-Pick Position With a Direct Laryngoscopy and the Classic Approach With VideolaryngoscopyY
In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity.
Data were analyzed with the generalized linear mixed-effects models.
Primary endpoint was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded as secondary endpoints.
- Being tested
- Videolaryngoscopy / Direct Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscopy / Direct LaryngoscopyDevice
First pass success analysis
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscopy in the ice-pick position | Experimental | In this arm, participants are assigned to intubations attempts in weightlessness on a manikin.
The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a direct laryngoscope with a Macintosh non-angulated size 3 blade, in a "face-to-face" or ice-pick position. Receives: Device: Videolaryngoscopy / Direct Laryngoscopy |
| Video-laryngoscopy in free-floating position | Experimental | In this arm, participants are assigned to intubations attempts in weightlessness on a manikin.
The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a video laryngoscopy in a semi-free-floating position (McGrath model, Covidien™, Medtronic™). Receives: Device: Videolaryngoscopy / Direct Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success
Bi-pulmonary ventilation success was assessed by the intubating operator performing chest auscultation and by the measurement of a tidal volume on the mannequin's electronic sensors. Selective side intubation was considered as failure
Measured: 1 day (1 flight)
Secondary outcomes (2)
Time
The duration (seconds) of each attempt was recorded and ended with vocal confirmation of tube placement from the intubating operator or at the end of the parabola
Measured: 1 day (1 flight)
Confidence Score
A subjective score of confidence in the correct tube placement was recorded after each attempt and ranked from minus ten (complete certainty about failure) to plus ten (complete certainty about success). A score of zero was pronounced by the operator when he/she had maximum uncertainty about success or failure.
Measured: 1 day (1 flight)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Sep 2019
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- A simulation study, in which participants alternatively perform oro-tracheal intubation on a manikin, either using a videolaryngoscope (McGrath model, Medtronic TM) or a direct laryngoscope
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de Bretagne Sud
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National d'Etudes Spatiales
- Responsible party
- Principal investigator, Dr Seamus Thierry, Groupe Hospitalier de Bretagne Sud
- Investigators
- Séamus Thierry, MD, Principal investigator, Groupe Hospitalier de Bretagne Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303948
- Sponsor's protocol ID
- 2019-1
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All relevant data, anonymized, will be available from Dr S.Thierry on request
Publications
Thierry S, Jaulin F, Starck C, Aries P, Schmitz J, Kerkhoff S, Bernard CI, Komorowski M, Warnecke T, Hinkelbein J. Evaluation of free-floating tracheal intubation in weightlessness via ice-pick position with a direct laryngoscopy and classic approach with indirect videolaryngoscopy. NPJ Microgravity. 2023 Sep 8;9(1):73. doi: 10.1038/s41526-023-00314-y.
PubMed 37684267
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of Two Positions for Free Floating Tracheal Intubation in Weightlessness: An Ice-Pick Position With a Direct Laryngoscopy and the Classic Approach With VideolaryngoscopyY
- ClinicalTrials.gov ID
- NCT05303948
- Acronym / sponsor ID
- 2019-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Groupe Hospitalier de Bretagne SudUniversity, hospital or other
- Collaborators
- Centre National d'Etudes Spatiales
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 31 Mar 2022 (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 a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity.
Data were analyzed with the generalized linear mixed-effects models.
Primary endpoint was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded as secondary endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A simulation study, in which participants alternatively perform oro-tracheal intubation on a manikin, either using a videolaryngoscope (McGrath model, Medtronic TM) or a direct laryngoscope
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscopy in the ice-pick position | Experimental | Device: Videolaryngoscopy / Direct LaryngoscopyIn this arm, participants are assigned to intubations attempts in weightlessness on a manikin. The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a direct laryngoscope with a Macintosh non-angulated size 3 blade, in a "face-to-face" or ice-pick position. |
| Video-laryngoscopy in free-floating position | Experimental | Device: Videolaryngoscopy / Direct LaryngoscopyIn this arm, participants are assigned to intubations attempts in weightlessness on a manikin. The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a video laryngoscopy in a semi-free-floating position (McGrath model, Covidien™, Medtronic™). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers
- aged between 18 and 65 years old.
- Absence of pregnancy
- Belonging to a Health Insurance Coverage by the French Social Security Program or equivalent, proved by a European Health Insurance Card (EHIC).
- Medically fit to fly after a JAR FCL3 - Class 2 examination
Key exclusion criteria (5 listed)
- positive pregnancy test on flight day
- anxiety
- non-participation in flight safety briefing
- failure to follow safety guidelines
- occurence of motion sickness during the procedure
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 / Direct LaryngoscopyFirst pass success analysis | Device | Direct laryngoscopy in the ice-pick position, Video-laryngoscopy in free-floating position |
Primary outcome
First pass success
Time frame: 1 day (1 flight)
Bi-pulmonary ventilation success was assessed by the intubating operator performing chest auscultation and by the measurement of a tidal volume on the mannequin's electronic sensors. Selective side intubation was considered as failure
2 secondary outcomes
Time
Time frame: 1 day (1 flight)
Confidence Score
Time frame: 1 day (1 flight)
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 31 Mar 2022.
- Derived from this study: PubMed 37684267Thierry S, Jaulin F, Starck C, Aries P, Schmitz J, Kerkhoff S, Bernard CI, Komorowski M, Warnecke T, Hinkelbein J. Evaluation of free-floating tracheal intubation in weightlessness via ice-pick position with a direct laryngoscopy and classic approach with indirect videolaryngoscopy. NPJ Microgravity. 2023 Sep 8;9(1):73. doi: 10.1038/s41526-023-00314-y.
- Individual participant dataSharing planned: Yes. All relevant data, anonymized, will be available from Dr S.Thierry on request
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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.
Séamus Thierry, MD principal investigator
Groupe Hospitalier de Bretagne Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscopy / Direct Laryngoscopy in people with Intubation; Difficult or Failed and Intubation Complication, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
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 5 inclusion and 5 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 31 Mar 2022. 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 France. 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?
First pass success (time frame: 1 day (1 flight)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05303948, which also lists 1 linked publication.
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 31 Mar 2022.