Neck Position and Ultrasound Landmark of Cricothyroid Membrane

October 15, 2019 updated by: Christopher Prabhakar, University of British Columbia

Changes in Ultrasound-guided Skin Markings of the Cricothyroid Membrane in Three Different Neck Positions: a Prospective Observational Pilot Study

Cricothyroid membrane (CTM) localization is a critical step prior to emergent surgical airway access. Ultrasound-guided localization of the CTM on the skin of the neck had been suggested prior to induction of general anesthesia so that a marked entry point can be used to quickly establish emergent front of neck access if required. In this prospective observational study, the investigators aim to determine the potential for migration of the CTM markings in the sagittal plane during neck repositioning.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

As defined in recent difficult airway guidelines, successful and rapid cricothyroidotomy depends on identification of the cricothyroid membrane (CTM), coupled with skillful and efficient technique. Unfortunately, identification of the CTM is often inaccurate and complicated by patient factors such as female gender and obesity. Further studies go on to demonstrate the rates for correct identification of the CTM using palpation methods are low and range between 11% and 42%, with even lower success of identifying the midline of the CTM. This traditional palpation method was demonstrated to be fraught with error by different users including: 2 finger palpation, 4 finger palpation, and neck crease successfully identified the CTM 62%, 46%, and 50% of the time at time intervals between 11-14 seconds in non emergency settings.

As a result of previously mentioned patient factors and multiple technical factors, including poor landmarking, cricothyrotomy has a failure rate as high as 60%, exposing patients to high risks of mortality and morbidity. Therefore, more accurate methods of CTM identification are greatly needed at present.

Suggestions of implementing ultrasound in airway management have been brought forth, with applications such as predicting airway difficulty prior to instrumentation, confirming endotracheal tube position, or marking the CTM prior to induction of anesthesia. There have been multiple studies addressing questions such as mean time to identification of CTM in obese subjects using ultrasound and comparison of transverse versus longitudinal scanning technique. One group assessed translational movement of the CTM in neutral neck position versus extended in 23 healthy volunteers, and found a difference in transverse and longitudinal markings of 0.91mm and 1.04mm respectively, with CTM length ranging from 10.6mm to 17mm.

Of interest to the investigators is using ultrasound to predict CTM position accurately and ensuring ability to gain emergency airway access, as the accuracy of ultrasound identification of the CTM in different neck positions is unknown. What is specifically unknown is the translational movement of the cricoid between neck positions.

Therefore, the investigators propose an observational prospective trial looking at cricoid cartilage translation with three different neck positions: neck neutral, neck extension, and neck sniffing. The investigators will use GE Venue 50 (GE HealthcareTM) ultrasound machine, and a linear transducer probe with a frequency of 8-13MHz (GE LOGIQ 12L-SC) for measurements. The measurements will originate at the sternal notch to the superior border of the cricoid cartilage where the cricoid membrane inserts. These will also be referenced to exterior skin markings. The outcomes will address if the airway significantly moves during manipulation by the degree of cricoid cartilage translation between neutral, sniffing and extended neck positions. Secondarily, The investigators will also aim to address the directionality of a pre-marked neck and cricoid migration with neck manipulation.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult volunteers over age 19

Description

Inclusion

  • Patients aged between 19 and 90
  • Scheduled for elective surgeries

Exclusion

  • history of cricothyrotomy
  • history of tracheostomy
  • history of thyroidectomy
  • history of plastic surgery or neck skin flaps
  • history of neck lymph node dissections
  • history of open carotid endarterectomy
  • history of cervical instrumentation
  • history of neck deformities (acquired or congenital)
  • history of allergic reactions to adhesive tapes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cricothyroid membrane movement measured with ultrasound
Time Frame: 14 months
The primary outcome was the distance measured from superior border of the cricoid cartilage to the sternal notch in the sagittal plane between the three neck positions
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Directionality of cricothyroid membrane movement measured by ultrasound
Time Frame: 14 months
Directionality of the movement of the CTM during neck positions in relation to the sternal notch
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

October 9, 2019

Study Completion (Actual)

October 9, 2019

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • H18-01601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participants data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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