ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

Early Detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Difficult intubation, defined as a Cormac-Lehane grade of 3 and above

Timepoint [1]

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]

The correlation of hyomental distance ratio measured via ultrasound to a difficult intubation

Timepoint [1]

On the day of surgery, between 1 and 10hours before intubation

Secondary outcome [2]

The correlation of anterior neck thickness at the level of the cricoid ring measured by ultrasound to difficult intubation

Timepoint [2]

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?

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)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lyell McEwin Hospital

Address [1]

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country [1]

Australia

Primary sponsor type

Individual

Name

Yasmin Endlich

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (TQEH/LMH/MH) CALHN Research Office

Ethics committee address [1]

Ground Floor, Basil Hetzel Institute for Translational Health Research, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/08/2015

Approval date [1]

09/12/2015

Ethics approval number [1]

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

Dr Yasmin Endlich

Address

Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia

Country

Australia

Phone

+61 8 8222 4000

Fax

yasmin.endlich@gmail.com

Contact person for public queries

Name

Yasmin Endlich

Address

Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia

Country

Australia

Phone

+61 8 8222 4000

Fax

yasmin.endlich@gmail.com

Contact person for scientific queries

Name

Yasmin Endlich

Address

Royal Adelaide Hospital
Port Road
Adelaide, 5000
South Australia

Country

Australia

Phone

+61 8 8222 4000

Fax

yasmin.endlich@gmail.com

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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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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