Airway MorbidityFOINCT04158323
What is the Gold Standard of Airway Management in the Anticipated Difficult Airway
An observational study of Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Airway Management in patients with a anticipated difficult airway
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 23 Nov 2019to 23 Dec 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: anesthesists and intensive care physicians
Who may be able to join
- experience in anesthesia or intensive care
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Survey on the Current Significance of the Flexible Endoscopy as the Gold Standard for Airway Management in Patients With Anticipated Difficult Airway
A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals.
Read the detailed description
The aim of the study is to analyze the current significance of the awake flexible endoscopy in German hospitals, to identify strategies to securing the airway in patients with a anticipated difficult airway. The participants complete a pre-prepared questionnaire.
- Conditions
- Airway Morbidity
- Being tested
- Airway Management in patients with a anticipated difficult airway
- Keywords
- flexible endoscopy, awake intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Management in patients with a anticipated difficult airwayDevice
survey of anesthesists and intensive care physician of the perfomans with the flexible endoscope in patients with a anticipated difficult airway
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the current practice for Airway Management in patients with a anticipated difficult airway?
Evaluation of the current practice to secure the airway in patients with a anticipated difficult airway
Measured: through study completion, an average of 10 minutes
Secondary outcomes (1)
What is the most preferred technique for awake flexible endoscopy?
Evaluation of application (nasal/oral), local anesthestics
Measured: through study completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start23 Nov 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158323
- Sponsor's protocol ID
- JohannesGUF
- Acronym
- FOI
- Status last verified
- Dec 2019
- First submitted
- 6 Nov 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Current Significance of the Flexible Endoscopy as the Gold Standard for Airway Management in Patients With Anticipated Difficult Airway
- ClinicalTrials.gov ID
- NCT04158323
- Acronym / sponsor ID
- FOI / JohannesGUF
- Conditions
- Airway Morbidity
- Keywords
- flexible endoscopy, awake intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 23 Nov 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 8 Nov 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.
A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals.
Detailed description
The aim of the study is to analyze the current significance of the awake flexible endoscopy in German hospitals, to identify strategies to securing the airway in patients with a anticipated difficult airway. The participants complete a pre-prepared questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- anesthesists and intensive care physicians
Key inclusion criteria (1 listed)
- experience in anesthesia or intensive care
Key exclusion criteria (1 listed)
- no
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 in patients with a anticipated difficult airwaysurvey of anesthesists and intensive care physician of the perfomans with the flexible endoscope in patients with a anticipated difficult airway | Device | – |
Primary outcome
What is the current practice for Airway Management in patients with a anticipated difficult airway?
Time frame: through study completion, an average of 10 minutes
Evaluation of the current practice to secure the airway in patients with a anticipated difficult airway
1 secondary outcome
What is the most preferred technique for awake flexible endoscopy?
Time frame: through study completion, an average of 10 minutes
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 24 Dec 2019.
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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.
Marc Kriege, MD principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Morbidity, run by Johannes Gutenberg University Mainz 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 24 Dec 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 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?
What is the current practice for Airway Management in patients with a anticipated difficult airway? (time frame: through study completion, an average of 10 minutes). 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 24 Dec 2019.