Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia
| ISRCTN | ISRCTN34940667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34940667 |
| Protocol serial number | 18637/20.09.2016 |
| Sponsor | The Clinical Emergency County Hospital Cluj |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
No. 14, Eftimie Murgu Street
Cluj-Napoca
400604
Romania
| Phone | +40 (0)722 262 286 |
|---|---|
| petrisor.cristina@umfcluj.ro |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective diagnostic study |
| Secondary study design | Prospective diagnostic study |
| Study type | Participant information sheet |
| Scientific title | Ultrasonographic evaluation of the submandibular space compliance to predict difficult airway in anaesthesia: a prospective diagnostic study |
| Study acronym | HIO-MENTO US |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(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 |
| Key secondary outcome measure(s) |
Laryngeal view, assessed using the Cormack grade at induction of anaesthesia during the first laryngoscopy attempt |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | Patients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation |
| Key exclusion criteria | 1. Rapid sequence induction 2. External laryngeal manipulation during laryngoscopy 3. Emergency surgery 4. Videolaringoscopy |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Romania
Study participating centre
Cluj-Napoca
400006
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2018: Publication references added.
