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Ultrasound to Predict Difficult Airway

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ClinicalTrials.gov Identifier: NCT03789071
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Efrain Riveros Perez, MD, Augusta University

Brief 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. 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.

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.


Condition or disease Intervention/treatment
Difficult Intubation Diagnostic Test: External ultrasound evaluation of the airway

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Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Upper Airway Ultrasound-derived Indexes as Predictors of Difficult Airway
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Patient scheduled for general anesthesia with intubation
Patients in this group (only group) will have clinical airway assessment and external ultrasound assessment of the airway
Diagnostic Test: External ultrasound evaluation of the airway
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.




Primary Outcome Measures :
  1. Ultrasound depth of the tongue [ Time Frame: 10 minutes ]
    With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to tongue will be measured.

  2. Degree of glottic visualization [ Time Frame: 10 minutes ]
    During laryngoscopy, percentage of glottic opening will be recorded


Secondary Outcome Measures :
  1. Ultrasound depth of cricoid cartilage [ Time Frame: 10 minutes ]
    With curvilinear ultrasound probe in longitudinal position over upper neck, the distance from probe to the cricoid cartilage will be measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient scheduled for elective surgery under general anesthesia in whom tracheal intubation is planned.
Criteria

Inclusion Criteria:

  • Elective surgery
  • Age older than 18 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789071


Contacts
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Contact: Efrain Riveros Perez, MD 3304074681 eriverosperez@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Steffen Meiler, MD    706-721-3671    smeiler@augusta.edu   
Sponsors and Collaborators
Augusta University

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Responsible Party: Efrain Riveros Perez, MD, Assistant Professor. Department of Anesthesiology, Augusta University
ClinicalTrials.gov Identifier: NCT03789071     History of Changes
Other Study ID Numbers: 1218610
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No