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Difficult IntubationNCT03789071

Ultrasound to Predict Difficult Airway

An observational study of Difficult Intubation, run by Augusta University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Upper airway ultrasound is a valuable, non-invasive, simple, and portable point of care tool for evaluation of the airway, even in the presence of anatomic distortion caused by pathology or trauma. The ultrasound technology is being increasingly adopted in modern anesthesiology practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Difficult Intubation
What is being tested?
External ultrasound evaluation of the airway
How many people
420 participants
Where
1 siteUnited States
Study dates
1 Feb 2019to 1 Mar 2023
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
  • Adult, Older adult

Study population: Patient scheduled for elective surgery under general anesthesia in whom tracheal intubation is planned.

Who may be able to join

  • Elective surgery
  • Age older than 18 years

Who cannot join

  • Emergency surgery
  • Nasal intubation
  • Intubation with fiberoptic scope or glidescope
  • Intubation without laryngoscopy
  • Awake intubation
  • Allergy to ultrasound gel

Trial locations and contacts

1 site in 1 country.

Efrain Riveros Perez, MD contact

3304074681

eriverosperez@augusta.edu

United States1 site, 1 recruiting
  • Augusta University

    Augusta, Georgia, 30912

    Steffen Meiler, MD, 706-721-3671, smeiler@augusta.edu

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Upper Airway Ultrasound-derived Indexes as Predictors of Difficult Airway

Upper airway ultrasound is a valuable, non-invasive, simple, and portable point of care tool for evaluation of the airway, even in the presence of anatomic distortion caused by pathology or trauma. The ultrasound technology is being increasingly adopted in modern anesthesiology practice. As early as in 1984, some authors have recommended its use to guide venous cannulation, because it shortens procedural times, reduces the number of failed puncture attempts, and minimizes complications. On the other hand, ultrasound-guided techniques are considered the gold standard for peripheral nerve blocks.

As ultrasound becomes more widespread, it is important to for anesthesiologists to be aware of the expanding applications of this technology. Current and potential future applications of ultrasound in anesthesiology are wide and include regional anesthesia, neuraxial and chronic pain procedures, vascular access, airway assessment, lung ultrasound, ultrasound neuro-monitoring, gastric ultrasound, focused transthoracic echography, trans-esophageal echocardiography and vascular Doppler flow assessment. The major disadvantage is inter-observer variability, and the fact that it requires is a unique skill that requires continuing training and experience to master the technology. In order to be successful with this technique, it is important to develop a thorough understanding of the sonoanatomy. The normal or abnormal structures need to be imaged and interpreted before any intervention.

Read more

Airway management is one of the most important tasks for anesthesiologists. Access to the airway should be safe, fast and efficient. Appropriate planning is crucial to avoid morbidity and mortality when difficulty is anticipated. Inability to maintain airway ventilation is a life-threatening situation that may warrant emergent surgical access to prevent devastating consequences. A thorough assessment of the airway is recommended to predict difficulty. Multiple clinical predictors have been used in clinical practice; however, most of them are associated with low predictive values. In consequence, a comprehensive airway examination that incorporates both quantitative and qualitative tests increases the probability of predicting difficult intubation. Regardless of the method of airway evaluation, it is important to acknowledge that clinical airway assessment is not fully accurate and can produce both false-negative and false-positive results.

There is a growing academic interest in the ability of ultrasound to determine airway size to estimate appropriate endotracheal tube size. Ultrasound enables us to identify important sonoanatomy of the upper airway including thyroid cartilage, epiglottis, cricoid cartilage, cricothyroid membrane, tracheal cartilages, and esophagus. Transverse and parasagittal views can help diagnose supraglottic, glottic and infraglottic airway conditions and aid the anesthesiologist in airway management. Ultrasonography has brought a paradigm shift in the practice of airway management. With increasing awareness, portability, accessibility and further sophistication in technology, it is likely to find a place in routine airway management.

Being tested
External ultrasound evaluation of the airway

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External ultrasound evaluation of the airwayDiagnostic test

    Patients scheduled to have surgery under general anesthesia in whom tracheal intubation is planned, will have a clinical and ultrasound assessment of the airway before surgery. Information regarding laryngoscopy in the operating room will be recorded.

Study groups in NCT03789071
Study groupRoleWhat they receive
Patient scheduled for general anesthesia with intubationPatients in this group (only group) will have clinical airway assessment and external ultrasound assessment of the airway
Receives: Diagnostic Test: External ultrasound evaluation of the airway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ultrasound depth of the tongue

    With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to tongue will be measured.

    Measured: 10 minutes

  2. Degree of glottic visualization

    During laryngoscopy, percentage of glottic opening will be recorded

    Measured: 10 minutes

Secondary outcomes (1)
  1. Ultrasound depth of cricoid cartilage

    With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to the cricoid cartilage will be measured.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2018
  2. Study start1 Feb 2019
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03789071
Sponsor's protocol ID
1218610
Status last verified
Jul 2021
First submitted
26 Dec 2018
Last updated
22 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Difficult Intubation, run by Augusta University at 1 site in United States.

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 6 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 22 Jul 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 United States. 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 Efrain Riveros Perez, MD (3304074681, eriverosperez@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasound depth of the tongue (time frame: 10 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 22 Jul 2021.

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