Condition category
Respiratory
Date applied
21/03/2015
Date assigned
02/04/2015
Last edited
20/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Air containing oxygen, normally passes in and out of our nose or mouth to the lungs during normal breathing. In the event of rare and life-threatening emergency, this passage may become blocked or obstructed, and an alternative route that bypasses the nose or mouth is needed. This can be done with a small cut or window made in the front of the neck (the cricothyroid membrane) overlying the windpipe. Without this life-saving procedure, the patient will be starved of oxygen and may come to serious harm, or die. This is a very rare event, and many doctors will never perform even one of these in their lifetime. Correctly locating this point on the neck can be difficult, especially when a patient is very overweight. The current way of finding this point is by feeling for landmarks on the neck with fingers, known as “palpation”. This is known to be more difficult when the patient is very overweight and the landmarks of the windpipe underneath the neck are less easy to feel. Another way to find this point on the neck is by using ultrasound. This is a machine that can produce an image or picture of tissues underneath the skin onto a screen, so that a trained doctor can see the correct spot to aim for, even if they may not be able to feel it by the finger method. Our study is going to look at which of these two techniques is more accurate.

Who can participate?
Anaesthetists working at University College London Hospital ( UCLH).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are asked to locate the cricothyroid membrane using the finger "palpation" technique on an actor who is overweight.
Those in group 2 are asked to locate the cricothyroid membrane using ultrasound on an actor who is overweight. Assessments are made as to how quickly and easily the membrane is located.

What are the possible benefits and risks of participating?
There are no specific benefits for the participants, though they will receive education on ultrasound guided interventions in the neck. There are no risks to participants.

Where is the study run from?
University College London Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2016 to July 2016

Who is funding the study?
University College Hospital NHS Trust (UK)

Who is the main contact?
Dr Kirstie McPherson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kirstie McPherson

ORCID ID

http://orcid.org/0000-0002-8366-4886

Contact details

Dept of Anaesthetics
UCLH
235 Euston Road
London
NW1 2BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KMP1

Study information

Scientific title

Randomised control trial of ultrasound versus palpation-technique in identifying the cricothyroid membrane (CTM) in simulated can’t intubate, can’t ventilate scenario

Acronym

Study hypothesis

The principle research question is which of two methods is more accurate at correctly identifying the spot on the neck, under which lies the windpipe. At this point a "cut" or window can be made accessing the windpipe, providing a route for air to pass down into the lungs, bypassing the nose or mouth, where a blockage or obstruction lies. The first method relies on examining the neck with hands and fingers to locate this spot correctly, the second uses ultrasound, a machine that produces a picture or image of structures below the skin and invisible to the human eye. We will measure how accurate both methods are by randomly allocating anaesthetists to one of two groups (finger palpation and using ultrasound). We will ask them to find the correct point on the neck of an actor, marking this with "invisible ink". An experienced doctor will have marked this area beforehand (with invisible ink), enabling a measurement of how accurate and close to the expert's mark the subject has been using one of either techniques.

Ethics approval

On pre-review by ethics, it was decided that full ethical review was not required

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Can't intubate, can't ventilate scenarios

Intervention

Doctors are randomly assigned to one of two groups.
Group 1: Participants are asked to locate the cricothyroid membrane using the finger "palpation" technique on an actor who is overweight
Group 2: Participants are asked to locate the cricothyroid membrane using ultrasound on an actor who is overweight

Intervention type

Device

Phase

Drug names

Primary outcome measures

Ease of identification of the cricothyroid membrane with ultrasound in a simulated CICV scenario.

Secondary outcome measures

Speed of identification of cricothyroid membrane using ultrasound

Overall trial start date

01/05/2016

Overall trial end date

01/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Anaesthetists working at UCLH

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Unwilling to consent to taking part

Recruitment start date

01/05/2016

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital
235 Euston Rd
London
-

Sponsor information

Organisation

University College Hospital NHS Trust (UK)

Sponsor details

235 Euston Rd
London
WD6 3HH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University College Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We anticipate the results of the trial will be published in an international anaesthetic journal for dissemination of the lessons learned.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 20/04/2016 the following changes were made to the trial record: 1. The overall trial start date was changed from 01/06/2015 to 01/05/2016. 2. The overall trial end date was changed from 30/06/2015 to 01/07/2016.