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Completed

NCT Number: NCT04124770

Neck Position and Ultrasound Landmark of Cricothyroid Membrane

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.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Movement

Other

Re-positioning of neck

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2019
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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