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

ISRCTN ISRCTN34940667
DOI https://doi.org/10.1186/ISRCTN34940667
Secondary identifying numbers 18637/20.09.2016
Submission date
21/11/2016
Registration date
25/11/2016
Last edited
09/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Oro-tracheal intubation is the placement of a flexible plastic tube through the mouth into the trachea (windpipe) to maintain an open airway. This is required during general anaesthesia, when the patient is connected to a breathing machine (ventilator). Managing the airway is an important skill for anaesthesiologists. It is important for the anaesthesiologist to assess the airway correctly in order to avoid hypoxemic events (low blood oxygen levels) and their consequences. The aim of this study is to find out whether an assessment of the anatomy of the airway can be used to predict the occurrence of airway difficulties in patients undergoing surgery.

Who can participate?
Patients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation

What does the study involve?
On the day before they undergo surgery, participants undergo an ultrasound scan of the anterior (front) region of the neck to look at the airway structures. Airway difficulties are assessed when the participants are intubated during general anaesthesia.

What are the possible benefits and risks of participating?
The results of this study could help us predict airway difficulties, thereby decreasing the risk of illness or death due to low blood oxygen levels. There are no risks for the participants as ultrasound is non-invasive and does not involve radiation.

Where is the study run from?
The Clinical Emergency County Hospital Cluj (Romania)

When is the study starting and how long is it expected to run for?
October 2016 to June 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Cristina Petrisor
petrisor.cristina@umfcluj.ro

Contact information

Dr Cristina Petrisor
Scientific

No. 14, Eftimie Murgu Street
Cluj-Napoca
400604
Romania

Phone +40 (0)722 262 286
Email petrisor.cristina@umfcluj.ro

Study information

Study designProspective diagnostic study
Primary study designObservational
Secondary study designProspective diagnostic study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleUltrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia: a prospective diagnostic study
Study acronymHIO-MENTO US
Study objectivesTo investigate the ability of ultrasound to evaluate the submandibular space compliance as a predictor for difficult airway in anaesthesia.
Ethics approval(s)The Ethics Committee of the Clinical Emergency County Hospital Cluj, 20/09/2016, ref: 18637
Health condition(s) or problem(s) studiedManagement of the difficult airway
InterventionAfter 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.
Intervention typeOther
Primary outcome measureSubmandibular 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 measuresLaryngeal view, assessed using the Cormack grade at induction of anaesthesia during the first laryngoscopy attempt
Overall study start date01/10/2016
Completion date30/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteriaPatients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation
Key exclusion criteria1. Rapid sequence induction
2. External laryngeal manipulation during laryngoscopy
3. Emergency surgery
4. Videolaringoscopy
Date of first enrolment01/10/2016
Date of final enrolment30/06/2017

Locations

Countries of recruitment

  • Romania

Study participating centre

The Clinical Emergency County Hospital Cluj
No.3-5, Clinicilor Street
Cluj-Napoca
400006
Romania

Sponsor information

The Clinical Emergency County Hospital Cluj
Hospital/treatment centre

No 3-5, Clinicilor Street
Cluj-Napoca
400006
Romania

ROR logo "ROR" https://ror.org/05j4kzc41

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/10/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe abstract will be presented at a conference in 2017 and the full original paper will be published in an anaesthesia journal.
IPD sharing planAll data will be registered in a database and, provided patient confidentiality is protected, can be made available by contacting Cristina Petrisor (petrisor.cristina@umfcluj.ro).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2018 Yes No

Editorial Notes

09/08/2018: Publication references added.