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Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy

NCT03547193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-06-06

No results posted yet for this study

Summary

Background: Unpredictable laryngoscopic difficulty remains a dramatic challenge for anaesthesiologists. Ultrasound (US) based airway assessment has been recently proposed as a useful tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation.

The aim of this study is to determine the correlation between the sonographic measurements of anterior cervical soft tissues's thickness and Cormack-Lehane grade view at direct laryngoscopy in patients with normal clinical screening tests.

Design: Prospective, single blinded, observational study. Number of patients: 300 adult patients Methods: All patients are assessed before surgery to evaluate clinical evidence of difficult airways. Simultaneous ultrasound measures of the anterior cervical soft tissues are performed.

At induction of anaesthesia the laryngoscopic view is graded by a different anaesthetist, blinded to the ultrasound assessments.

Statistical analysis:

Receiver operating characteristic curves (ROC) are used to determine the "difficulty prediction capability" of each sonographic measurement and to assess the optimal cut-off scores To allow for comparisons between "restricted-difficult" airway and "easy" airway groups, a two-sided Student's t-test and Fisher's exact test is employed as appropriate. The results will be averaged (mean ± standard deviation SD) for each parameter for continuous data. Values of p \< 0.05 are considered as statistically significant.

Conditions

  • Anesthesia
  • Airway Complication of Anesthesia
  • Difficult Intubation

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Abele Donati, MD, PhD · UNIVPM, University of Ancona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547193 on ClinicalTrials.gov