Upper Airway Ultrasound Evaluation

NCT06701253 | Recruiting

• 1 other identifier: 768
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines support the use of predictive clinical tests in the evaluation of difficult airway, meaning either difficult bag and mask ventilation, conventional laryngoscopy and/or endotracheal intubation. However, despite the clinical use of these predictive tests, unpredictive difficult laryngoscopy complicates 1.5-13% of cases. Life threatening scenarios may be encountered in patients with difficult or impossible bag and mask ventilation. Anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and central vascular access representing the most popular applications during the last decades. The ultrasound provides real time and accurate images. According to the current literature, there are only a handful of studies relevant to the application of point of care ultrasound (POCUS), as a new tool in the upper airway evaluation. It is a new field of research with high interest. This is a prospective observational study to investigate if specific ultrasound measurements of the anterior neck can serve as predictors of difficult airway. The ultrasound parameters will be measured preoperatively, during the preanaesthetic evaluation, along with standard clinical prognostic tools, like the mallampati score. The ultrasound parameters to be investigated are:

1. 1.the distance from thyroid isthmus to skin surface,
2. 2.the distance from the hyoid bone to the skin surface,
3. 3.the distance from the anterior commissure of vocal cords to the skin surface,
4. 4.the distance from skin to the trachea at the level of jugular notch,
5. 5.the distance from skin to epiglottis corresponding to half of the distance between thyroid cartilage and hyoid bone,
6. 6.and the angle between glottis and epiglottis. After the induction in anaesthesia, the Cormack Lehane score (grading of the laryngoscopy view) and the Han scale (grading of the degree of difficulty of bag and mask ventilation) will also be recorded.

Conditions

Airway Management; Point of Care; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Incidence of difficult intubation

  Difficult intubation is defined as requirement of more than three attempts with conventional laryngoscopy.

  From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.

• Incidence of difficult bag and mask ventilation

  Difficult mask ventilation is defined as the inability of an unassisted anesthesiologist to maintain the measured oxygen saturation as measured by pulse oximetry \> 92% or to prevent or reverse signs of inadequate ventilation during positive-pressure mask ventilation under general anesthesia.

  From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.

Secondary Outcomes (8)

• Cormack-Lehane classification

  From the beginning of the pre-oxygenation period up to the first, second or third attempt of conventional laryngoscopy, whichever comes first.

• Han scale classification

  From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.

• Distance from thyroid isthmus to skin surface

  24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.

• Distance from hyoid bone to skin surface

  24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.

• Distance from anterior commissure to skin surface

  24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.

Interventions

point of care ultrasound DIAGNOSTIC_TEST

Point of care ultrasound for upper airway evaluation.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General surgical population.

You may not qualify if:

• obstetric surgeries,
• pregnancy,
• non elective surgeries,
• patients with previous surgeries involving the anterior surface of the neck (i.e., thyroid surgery),
• patients with history of cervical radiation.

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Epirus, 455 00, Greece

RECRUITING

Central Study Contacts

Agathi Karakosta

CONTACT

0030 2651099766; akarakosta@uoi.gr

Danai Pantazi

CONTACT

0030 2651099766; pantazidanai@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 22, 2024
• Study Start: November 8, 2021
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): June 9, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

GR (1)