NCT03547193

Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy

Completed Last updated 6 June 2018

What this trial tests

trial in Anesthesia in 300 participants. Completed in 30 August 2017.

Timeline

5 May 2017

Primary endpoint
30 August 2017

30 August 2017

Quick facts

Lead sponsor	Università Politecnica delle Marche
Status	Completed
Study type	OBSERVATIONAL
Enrollment	300
Start date	5 May 2017
Primary completion	30 August 2017
Estimated completion	30 August 2017
Sites	1 location across Italy

Conditions studied

• Anesthesia — all drugs for Anesthesia →
• Airway Complication of Anesthesia — all drugs for Airway Complication of Anesthesia →
• Difficult Intubation — all drugs for Difficult Intubation →

Sponsor

Università Politecnica delle Marche — full company profile →

Who can join

18 and older, any sex, with Anesthesia or Airway Complication of Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of two neck ultrasound measurements as predictors of difficult direct laryngoscopy: A prospective observational study.
   Falcetta S, Cavallo S, Gabbanelli V, Pelaia P, et al · · 2018 · cited 77× · PMID 29889671 · DOI 10.1097/eja.0000000000000832