Airway ManagementAirMicroModNCT03848559
Airway Management With Simulated Microgravity Using a Submerged Model
A study testing Airway management with a submerged model in people with Airway Management and Emergency Medicine, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management, Emergency Medicine
- What is being tested?
- Airway management with a submerged model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anaesthesiologist with diver licence or Emergency physician with diver license
Who cannot join
- All other
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model.
Read the detailed description
Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins is going to be used for performing airway management. Each diver attempted airway management with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted laryngoscope. The time for airway protection will be measured as well as the success rate.
- Conditions
- Airway Management, Emergency Medicine
- Being tested
- Airway management with a submerged model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway management with a submerged modelDevice
Airway management with a submerged manikin using different airway devices in randomized order
| Study group | Role | What they receive |
|---|---|---|
| Airway device placement | Experimental | airway device is placed during the dive Receives: Device: Airway management with a submerged model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inserts
Summarizing the number of Intubation attempts or attempts to place the supraglottic airway
Measured: after 5 minutes
Time to first ventilation
Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation
Measured: after 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Hinkelbein, MD, PhD, Study chair, UK Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848559
- Sponsor's protocol ID
- AirMicroMod
- Acronym
- AirMicroMod
- Status last verified
- Jul 2020
- First submitted
- 14 Feb 2019
- Last updated
- 27 Jul 2020
- 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 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management With Simulated Microgravity Using a Submerged Model
- ClinicalTrials.gov ID
- NCT03848559
- Acronym / sponsor ID
- AirMicroMod / AirMicroMod
- Conditions
- Airway Management, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 Feb 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.
Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model.
Detailed description
Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins is going to be used for performing airway management. Each diver attempted airway management with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted laryngoscope. The time for airway protection will be measured as well as the success rate.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway device placement | Experimental | Device: Airway management with a submerged modelairway device is placed during the dive |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anaesthesiologist with diver licence or Emergency physician with diver license
Key exclusion criteria (1 listed)
- All other
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 |
|---|---|---|
| Airway management with a submerged modelAirway management with a submerged manikin using different airway devices in randomized order | Device | Airway device placement |
Primary outcome
Number of inserts
Time frame: after 5 minutes
Summarizing the number of Intubation attempts or attempts to place the supraglottic airway
Time to first ventilation
Time frame: after 5 minutes
Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation
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 27 Jul 2020.
- 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.
Jochen Hinkelbein, MD, PhD study chair
UK Köln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway management with a submerged model in people with Airway Management and Emergency Medicine, run by Universitätsklinikum Köln at 1 site in Germany.
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 1 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 27 Jul 2020. 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 Germany. 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?
Number of inserts (time frame: after 5 minutes). The study lists 2 primary outcomes in all. 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 27 Jul 2020.