Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy

NCT03547193 | Completed

• 1 other identifier: 2016-0405
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

difficult laringoscopy; difficult airway; airway management

Outcome Measures

Primary Outcomes (1)

• median Distance Skin to Epiglottis (mDSE)

  The median Distance Skin to Epiglottis, unit of measure cm, is detected using a US linear probe (10-13-MHz) with the transducer placed in the transverse plane and the patient's head in neutral position. It represents the distance from the skin in the median axis and the epiglottis

  24 hours

Eligibility Criteria

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

Study Population

All the adult patients undergoing to pre-operative evaluation for elective surgery at AOU-University Hospital of Ancona

You may qualify if:

• Adult patients undergoing pre-operative evaluation for elective surgery

You may not qualify if:

• Predicted difficult intubation

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche

Ancona, 60126, Italy

Location

Related Publications (1)

• Falcetta S, Cavallo S, Gabbanelli V, Pelaia P, Sorbello M, Zdravkovic I, Donati A. Evaluation of two neck ultrasound measurements as predictors of difficult direct laryngoscopy: A prospective observational study. Eur J Anaesthesiol. 2018 Aug;35(8):605-612. doi: 10.1097/EJA.0000000000000832.

  PMID: 29889671 DERIVED

Study Officials

• Abele Donati, MD, PhD

  UNIVPM, University of Ancona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: June 6, 2018
• Study Start: May 5, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: June 6, 2018

Record last verified: 2018-05

Locations

IT (1)