NCT03789071

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

3.9 years

First QC Date

December 26, 2018

Last Update Submit

July 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ultrasound depth of the tongue

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

    10 minutes

  • Degree of glottic visualization

    During laryngoscopy, percentage of glottic opening will be recorded

    10 minutes

Secondary Outcomes (1)

  • Ultrasound depth of cricoid cartilage

    10 minutes

Study Arms (1)

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

Interventions

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.

Patient scheduled for general anesthesia with intubation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Elective surgery
  • Age older than 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Central Study Contacts

Efrain Riveros Perez, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor. Department of Anesthesiology

Study Record Dates

First Submitted

December 26, 2018

First Posted

December 28, 2018

Study Start

February 1, 2019

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations