Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia

• Register: ISRCTN
• Last refreshed on: 27 August 2018
• Main ID: ISRCTN34940667
• Date of registration: 25/11/2016
• Prospective Registration: No
• Primary sponsor: The Clinical Emergency County Hospital Cluj
• Public title: Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia
• Scientific title: Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia: a prospective diagnostic study
• Date of first enrolment: 01/10/2016
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN34940667
• Study type: Observational
• Study design: Prospective diagnostic study (Diagnostic)

Countries of recruitment

Romania

Contacts

• Name: Cristina Petrisor

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation
Exclusion criteria: 1. Rapid sequence induction
2. External laryngeal manipulation during laryngoscopy
3. Emergency surgery
4. Videolaringoscopy

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Management of the difficult airway
Not Applicable

Intervention(s)

After the Ethics Committee approval and signing the informed consent forms, adult patients scheduled to undergo general anaesthesia with oro-tracheal intubation are prospectively included. Exclusion criteria are morbid obesity and rapid sequence inductions. Each patient will undergo an ultrasound evaluation of the airway anatomy, focusing on submandibular space compliance. The HMDs (hyo-mandibular distances) are measured in neutral, sniffing, and maximal hyperextended positions, in mid-sagital plane, using a curvilinear ultrasound transducer. The airway ultrasound is performed one day prior to the surgical intervention under general anaesthesia. All intubations are performed in sniffing position, with Macintosh curved laryngoscope blades, with no external laryngeal manipulation. The Cormack grade is registered on first attempt of laryngoscopy. Grades 3 and 4 Cormack-Lehane are considered difficult airway. ROC (receiver operating characteristics) curve analysis is used.

Primary Outcome(s)

Submandibular space compliance (the ratio for the hio-mental distance in maximal hyperextended position and sniffing position to the same distance in neutral position), measured by airway ultrasound one day before surgery

Secondary Outcome(s)

Laryngeal view, assessed using the Cormack grade at induction of anaesthesia during the first laryngoscopy attempt

Secondary ID(s)

18637/20.09.2016

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

The Ethics Committee of the Clinical Emergency County Hospital Cluj, 20/09/2016, ref: 18637

Results

• Results available: Yes
• Date Completed: 30/06/2017