Difficult AirwayNCT05347121
Difficult Airway and Ultrasonographic Evaluation
An observational study of Difficult Airway, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was planned to evaluate the preoperative neck ultrasonography measurements as a predictor of difficult airway in adult patients who will undergo elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- difficult airway
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2021to 3 Nov 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included American Society of Anesthesiologists (ASA) physical status I-II-III, 120 patients over the age of 18 who would be operated under general anesthesia.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical condition I-II-III
Who cannot join
- . Uncooperative patients,
- pregnant women,
- patients who have had head and neck trauma/surgery,
- patients with a known history of difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Neck Ultrasound Measurements as a Difficult Airway Signification
In this study, it was planned to evaluate the preoperative neck ultrasonography measurements as a predictor of difficult airway in adult patients who will undergo elective surgery under general anesthesia.
- Conditions
- Difficult Airway
- Being tested
- difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult airwayDiagnostic test
ultrasonography of airway
| Study group | Role | What they receive |
|---|---|---|
| difficult airway | Not described Receives: Diagnostic Test: difficult airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
epiglottis-skin thickness
epiglottis-skin thickness is a marker of difficult airway
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start3 Sep 2021
- Primary completion28 Sep 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Ozge Cınar Kose, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347121
- Sponsor's protocol ID
- ZUSG1
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neck Ultrasound Measurements as a Difficult Airway Signification
- ClinicalTrials.gov ID
- NCT05347121
- Acronym / sponsor ID
- ZUSG1
- Conditions
- Difficult Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 26 Apr 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 this study, it was planned to evaluate the preoperative neck ultrasonography measurements as a predictor of difficult airway in adult patients who will undergo elective surgery under general anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| difficult airway | – | Diagnostic Test: difficult airway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included American Society of Anesthesiologists (ASA) physical status I-II-III, 120 patients over the age of 18 who would be operated under general anesthesia.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical condition I-II-III
Key exclusion criteria (4 listed)
- . Uncooperative patients,
- pregnant women,
- patients who have had head and neck trauma/surgery,
- patients with a known history of difficult airway
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 |
|---|---|---|
| difficult airwayultrasonography of airway | Diagnostic test | difficult airway |
Primary outcome
epiglottis-skin thickness
Time frame: one month
epiglottis-skin thickness is a marker of difficult airway
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 26 Apr 2022.
- 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?
An observational study of Difficult Airway, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 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 26 Apr 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 Turkey (Türkiye). 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?
epiglottis-skin thickness (time frame: one month). 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 26 Apr 2022.