Airway UltrasoundNCT06391840
Airway Ultrasound As an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery
An observational study of Airway Ultrasound, run by DIMITRIOS KATSAROS at 1 site in Greece.
Trial summary
The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Ultrasound
- What is being tested?
- Airway ultrasound
- How many people
- 1,200 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2023to 1 May 2025
- 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: All patients above 28 years of age listed for elective surgery.
Who may be able to join
- listed for elective surgery
- airway assessment is possible prior to anesthesia
Who cannot join
- refusal to be enrolled in study
- airway assessment is not possible prior to anesthesia
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
G. Gennimatas General Hospital
Athens, Attica, 11527
Panagiotis Chatzistavridis, +306972871556, cprthessaloniki@gmail.com
About this study
The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound.
- Conditions
- Airway Ultrasound
- Being tested
- Airway ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway ultrasoundOther
Pre-operative airway ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Patients listed for elective surgery | Not described Receives: Other: Airway ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent prognostic value of airway ultrasound in difficult laryngoscopy
Measured: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
Secondary outcomes (1)
Search of normal and pathological values in airway ultrasound measurements
Measured: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Airway UltrasoundStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DIMITRIOS KATSAROS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DIMITRIOS KATSAROS, G.Gennimatas General Hospital
- Investigators
- Dimitrios Katsaros, Principal investigator, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391840
- Sponsor's protocol ID
- GGennimatasGH 18418
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.
PubMed 34914641You-Ten KE, Siddiqui N, Teoh WH, Kristensen MS. Point-of-care ultrasound (POCUS) of the upper airway. Can J Anaesth. 2018 Apr;65(4):473-484. doi: 10.1007/s12630-018-1064-8. Epub 2018 Jan 18.
PubMed 29349733Adi O, Fong CP, Sum KM, Ahmad AH. Usage of airway ultrasound as an assessment and prediction tool of a difficult airway management. Am J Emerg Med. 2021 Apr;42:263.e1-263.e4. doi: 10.1016/j.ajem.2020.09.011. Epub 2020 Sep 14.
PubMed 32994082Osman A, Sum KM. Role of upper airway ultrasound in airway management. J Intensive Care. 2016 Aug 15;4:52. doi: 10.1186/s40560-016-0174-z. eCollection 2016.
PubMed 27529028Xu J, Wang B, Wang M, Yao W, Chen Y. The value of multiparameter combinations for predicting difficult airways by ultrasound. BMC Anesthesiol. 2022 Oct 5;22(1):311. doi: 10.1186/s12871-022-01840-0.
PubMed 36199026Gottlieb M, Holladay D, Burns KM, Nakitende D, Bailitz J. Ultrasound for airway management: An evidence-based review for the emergency clinician. Am J Emerg Med. 2020 May;38(5):1007-1013. doi: 10.1016/j.ajem.2019.12.019. Epub 2019 Dec 11.
PubMed 31843325
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Ultrasound As an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery
- ClinicalTrials.gov ID
- NCT06391840
- Acronym / sponsor ID
- GGennimatasGH 18418
- Conditions
- Airway Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- DIMITRIOS KATSAROSUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients listed for elective surgery | – | Other: Airway ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above 28 years of age listed for elective surgery.
Key inclusion criteria (2 listed)
- listed for elective surgery
- airway assessment is possible prior to anesthesia
Key exclusion criteria (2 listed)
- refusal to be enrolled in study
- airway assessment is not possible prior to anesthesia
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 ultrasoundPre-operative airway ultrasound | Other | Patients listed for elective surgery |
Primary outcome
Independent prognostic value of airway ultrasound in difficult laryngoscopy
Time frame: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
1 secondary outcome
Search of normal and pathological values in airway ultrasound measurements
Time frame: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 34914641Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.
- Background: PubMed 29349733You-Ten KE, Siddiqui N, Teoh WH, Kristensen MS. Point-of-care ultrasound (POCUS) of the upper airway. Can J Anaesth. 2018 Apr;65(4):473-484. doi: 10.1007/s12630-018-1064-8. Epub 2018 Jan 18.
- Background: PubMed 32994082Adi O, Fong CP, Sum KM, Ahmad AH. Usage of airway ultrasound as an assessment and prediction tool of a difficult airway management. Am J Emerg Med. 2021 Apr;42:263.e1-263.e4. doi: 10.1016/j.ajem.2020.09.011. Epub 2020 Sep 14.
- Background: PubMed 27529028Osman A, Sum KM. Role of upper airway ultrasound in airway management. J Intensive Care. 2016 Aug 15;4:52. doi: 10.1186/s40560-016-0174-z. eCollection 2016.
- Background: PubMed 36199026Xu J, Wang B, Wang M, Yao W, Chen Y. The value of multiparameter combinations for predicting difficult airways by ultrasound. BMC Anesthesiol. 2022 Oct 5;22(1):311. doi: 10.1186/s12871-022-01840-0.
- Background: PubMed 31843325Gottlieb M, Holladay D, Burns KM, Nakitende D, Bailitz J. Ultrasound for airway management: An evidence-based review for the emergency clinician. Am J Emerg Med. 2020 May;38(5):1007-1013. doi: 10.1016/j.ajem.2019.12.019. Epub 2019 Dec 11.
- Individual participant dataSharing planned: No
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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.
Dimitrios Katsaros principal investigator
G.Gennimatas General Hospital
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 Ultrasound, run by DIMITRIOS KATSAROS at 1 site in Greece.
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 2 inclusion and 2 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 7 Nov 2024. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Katsaros (+302132038490 ext. 8490, dimkats27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent prognostic value of airway ultrasound in difficult laryngoscopy (time frame: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered). 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 NCT06391840, which also lists 6 linked publications.
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 7 Nov 2024.