Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Dr Cristina Petrisor
ORCID ID
Contact details
No. 14
Eftimie Murgu Street
Cluj-Napoca
400604
Romania
+40 (0)722 262 286
petrisor.cristina@umfcluj.ro
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
18637/20.09.2016
Study information
Scientific title
Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia: a prospective diagnostic study
Acronym
HIO-MENTO US
Study hypothesis
To 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
Study design
Prospective diagnostic study
Primary study design
Observational
Secondary study design
Prospective diagnostic study
Study setting(s)
Hospital
Study type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Management of the difficult airway
Intervention
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.
Intervention type
Other
Primary outcome measure
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 measures
Laryngeal view, assessed using the Cormack grade at induction of anaesthesia during the first laryngoscopy attempt
Overall study start date
01/10/2016
Overall study end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
120
Participant exclusion criteria
1. Rapid sequence induction
2. External laryngeal manipulation during laryngoscopy
3. Emergency surgery
4. Videolaringoscopy
Recruitment start date
01/10/2016
Recruitment end date
30/06/2017
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
Organisation
The Clinical Emergency County Hospital Cluj
Sponsor details
No 3-5
Clinicilor Street
Cluj-Napoca
400006
Romania
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The abstract will be presented at a conference in 2017 and the full original paper will be published in an anaesthesia journal.
Intention to publish date
30/10/2017
Individual participant data (IPD) sharing plan
All 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).
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | Yes | No |