Condition category
Not Applicable
Date applied
21/11/2016
Date assigned
25/11/2016
Last edited
30/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2016

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged over 18 undergoing elective general anaesthesia with oro-tracheal intubation

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

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.

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).

Intention to publish date

30/10/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes