Airway Complication of AnesthesiaNCT04816435
Airway Ultrasound Assessment in the Prediction of Difficult Airway
An observational study of Airway Complication of Anesthesia and Anesthesia Intubation Complication, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia, Anesthesia Intubation Complication
- What is being tested?
- Ultrasound test
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Jan 2022
- 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: Patients under general anesthesia with orotracheal intubation
Who may be able to join
- Patients risk ASA I-IV
- Non-urgent surgery under general anesthesia with orotracheal intubation
- Acceptance to participate and grant written consent
Who cannot join
- Urgent surgery
- Patients with a history of craniocervical pathology (trauma, tumor, malformations)
- Pregnancy
- Patient Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway
To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.
- Being tested
- Ultrasound test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound testDiagnostic test
Ultrasound evaluation of airway
What is being measured
The primary outcome is the main question the study is designed to answer.
Pretracheal fat thickness for intubation complexity
The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
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 Airway Complication of AnesthesiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816435
- Sponsor's protocol ID
- FJD-ECOVAD-01
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Madrid-Vazquez L, Casans-Frances R, Gomez-Rios MA, Cabrera-Sucre ML, Granacher PP, Munoz-Alameda LE. Machine learning models based on ultrasound and physical examination for airway assessment. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Oct;71(8):563-569. doi: 10.1016/j.redare.2024.05.006. Epub 2024 May 31.
PubMed 38825182
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway
- ClinicalTrials.gov ID
- NCT04816435
- Acronym / sponsor ID
- FJD-ECOVAD-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under general anesthesia with orotracheal intubation
Key inclusion criteria (3 listed)
- Patients risk ASA I-IV
- Non-urgent surgery under general anesthesia with orotracheal intubation
- Acceptance to participate and grant written consent
Key exclusion criteria (4 listed)
- Urgent surgery
- Patients with a history of craniocervical pathology (trauma, tumor, malformations)
- Pregnancy
- Patient Refusal
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 |
|---|---|---|
| Ultrasound testUltrasound evaluation of airway | Diagnostic test | – |
Primary outcome
Pretracheal fat thickness for intubation complexity
Time frame: 5 minutes
The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 38825182Madrid-Vazquez L, Casans-Frances R, Gomez-Rios MA, Cabrera-Sucre ML, Granacher PP, Munoz-Alameda LE. Machine learning models based on ultrasound and physical examination for airway assessment. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Oct;71(8):563-569. doi: 10.1016/j.redare.2024.05.006. Epub 2024 May 31.
- 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 Airway Complication of Anesthesia and Anesthesia Intubation Complication, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. 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 Spain. 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?
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?
Pretracheal fat thickness for intubation complexity (time frame: 5 minutes). 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 NCT04816435, 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 25 Mar 2021.