Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000415202
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
21/03/2018
Date last updated
21/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utility of ultrasound assessment for predicting difficult intubation in adult surgical patients.
Scientific title
Utility of ultrasound assessment for predicting difficult intubation in adult surgical patients - a prospective observational study.
Secondary ID [1] 292684 0
nil known
Universal Trial Number (UTN)
U1111-1200-9358
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult intubation 304434 0
Condition category
Condition code
Anaesthesiology 303763 303763 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this prospective observational study we will assess the upper airway of patients presenting for surgery requiring endotracheal intubation in a tertiary hospital for potential difficult airway.
This will be done both clinically and using an M- Turbo SonoSite ultrasound machine. We will measure the hyomental distance in neutral and the hyperextended position and will assess the anterior neck thickness at the level of the hyoid and thyrohoid membrane on the day of surgery before the patients goes to the operating theatre. The approximate duration of the procedure will be less than 10 minutes.
Intervention code [1] 298917 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303133 0
Difficult intubation, defined as a Cormac-Lehane grade of 3 and above
Timepoint [1] 303133 0
The ease or difficulty of managing the patients airway during surgery assessed with a questionnaire specifically designed for this study and completed by the treating anaesthetist at the end of the procedure.
Secondary outcome [1] 337989 0
The correlation of hyomental distance ratio measured via ultrasound to a difficult intubation
Timepoint [1] 337989 0
On the day of surgery, between 1 and 10hours before intubation
Secondary outcome [2] 338262 0
The correlation of anterior neck thickness at the level of the cricoid ring measured by ultrasound to difficult intubation
Timepoint [2] 338262 0
Measured 1 - 10 hours before surgery

Eligibility
Key inclusion criteria
Patient eligible are adult patients requiring endotracheal intubation for surgery at the Lyell McEwin Hospital in Adelaide.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have any abnormalities preventing the use of clinical screening tests (facial fractures, maxillofacial abnormalities, tumors and cervical spine fractures), have a tracheostomy tube, are unable to give consent or will have their airway secured by a method other than with direct laryngoscopy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Data collection will be via a data sheet for each patient. Study data will then be transcribed on an excel spreadsheet for further analyses. Descriptive statistics will be used as appropriate and reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
1/08/2018
Actual
Date of last data collection
Anticipated
1/08/2018
Actual
Sample size
Target
350
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8828 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 16955 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 297326 0
Hospital
Name [1] 297326 0
Lyell McEwin Hospital
Country [1] 297326 0
Australia
Primary sponsor type
Individual
Name
Yasmin Endlich
Address
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 296299 0
None
Name [1] 296299 0
Address [1] 296299 0
Country [1] 296299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298428 0
Human Research Ethics Committee (TQEH/LMH/MH) CALHN Research Office
Ethics committee address [1] 298428 0
Ground Floor, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Ethics committee country [1] 298428 0
Australia
Date submitted for ethics approval [1] 298428 0
20/08/2015
Approval date [1] 298428 0
09/12/2015
Ethics approval number [1] 298428 0
HREC/15/TQEH/181

Summary
Brief summary
Difficult or failed intubation is a major and life threatening complication that may occur during induction of general anaesthesia. Thorough preoperative airway assessment is an important component of establishing a safe plan to secure patients’ airways perioperatively.
Ultrasound technology is rapidly evolving and becoming more accessible as costs decrease and devices become both more portable and user-friendlier. The use of the ultrasound in airway assessment has been described as early as the 1980s, and recently there has been increasing interest in the use of this technology among anaesthetists worldwide. Ultrasound used in conjunction with clinical airway assessment has multiple advantages and there is a rapidly growing body of evidence supporting its use. Ultrasound can be used to view the majority of the upper airway structures, including the mouth, tongue, oropharynx, hypopharynx, hyoid bone, larynx, vocal cords, cartilages, trachea and oesophagus.
In this prospective observational study we will assess the upper airway of patients presenting for surgery requiring endotracheal intubation in a tertiary hospital for potential difficult airway. This will be done both clinically and using an M- Turbo SonoSite ultrasound machine. We will measure the hyomental distance in neutral and the hyperextended position and will assess the anterior neck thickness at the level of the hyoid and thyrohoid membrane. Pre operative results and perioperative airway management including any difficulties with intubation will be documented and compared accordingly.
The objectives of this study are to determine the utility of the use of the ultrasound to predict a difficult intubation, and examine the association, if any, between ultrasound measurements and difficult airway clinical screening tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77050 0
Dr Yasmin Endlich
Address 77050 0
Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia
Country 77050 0
Australia
Phone 77050 0
+61 8 8222 4000
Fax 77050 0
Email 77050 0
[email protected]
Contact person for public queries
Name 77051 0
Dr Yasmin Endlich
Address 77051 0
Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia
Country 77051 0
Australia
Phone 77051 0
+61 8 8222 4000
Fax 77051 0
Email 77051 0
[email protected]
Contact person for scientific queries
Name 77052 0
Dr Yasmin Endlich
Address 77052 0
Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia
Country 77052 0
Australia
Phone 77052 0
+61 8 8222 4000
Fax 77052 0
Email 77052 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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