Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position

Difficult Intubation Clinical Trial

— ULOC  

Official title:

An Observational Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178318
• Other study ID #: 226475
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: January 16, 2018
• Start date: June 19, 2017
• Est. completion date: June 21, 2017

Study information

• Verified date: January 2018
• Source: Northampton General Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is traditionally provided using face mask, supraglottic airway (breathing tube above voice box) or endotracheal tube (breathing tube in wind pipe). However in some patients it may be impossible to provide oxygen through any of these above means which can be life threatening and lead to permanent brain damage/death. One of the ideal ways of managing this emergency situation is to pass a breathing tube through a membrane in the front of the neck called cricothyroid membrane with the neck in extension position where permitted. Many studies have recommended identifying the cricothyroid membrane before general anaesthesia in high risk patients but with their head in neutral position. This study will be a pilot study to check if the cricothyroid membrane remains in the same place in neutral and extended positions.

Description:

This is a non-randomised observational pilot study. The results of the study will be used to determine the size of the sample required for a planned randomised controlled trial in the future. All the volunteers will be asked to lie on a trolley with the head in neutral position- Defined as alignment of external auditory meatus (outer ear canal) to the sternal angle (prominent portion of breast bone) is horizontal. A radiologist trained in ultrasound of the neck will identify the position of upper and lower border of the cricothyroid membrane using ultrasound and then mark these borders and the centre point with a black surgical marker pen. Then the volunteer will be asked to extend the neck and the same steps will be repeated using a red surgical marker pen. The distance between the two centre points will then be measured using a calliper/ measuring scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Aged 18 years or above.

Exclusion Criteria:

• Age <18 years

• Inability to communicate or refuses consent

• History of problems with neck movement

• Arthritis of the neck

• Upper limb neurology

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Procedure:
• ultrasound
ultrasound of the neck to identify the position of upper and lower border of the cricothyroid membrane.

Locations

Country	Name	City	State
United Kingdom	Northampton General Hospital NHS Trust	Northampton

Sponsors (1)

Lead Sponsor	Collaborator
Northampton General Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Ai — View Citation

Campbell M, Shanahan H, Ash S, Royds J, Husarova V, McCaul C. The accuracy of locating the cricothyroid membrane by palpation - an intergender study. BMC Anesthesiol. 2014 Nov 22;14:108. doi: 10.1186/1471-2253-14-108. eCollection 2014. — View Citation

Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J — View Citation

Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubat — View Citation

Hochman II, Zeitels SM, Heaton JT. Analysis of the forces and position required for direct laryngoscopic exposure of the anterior vocal folds. Ann Otol Rhinol Laryngol. 1999 Aug;108(8):715-24. Review. — View Citation

Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24. — View Citation

Lamb A, Zhang J, Hung O, Flemming B, Mullen T, Bissell MB, Arseneau I. Accuracy of identifying the cricothyroid membrane by anesthesia trainees and staff in a Canadian institution. Can J Anaesth. 2015 May;62(5):495-503. doi: 10.1007/s12630-015-0326-y. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound measurement	The distance between the two centre points of the cricothyroid membrane when the head is kept in the neutral and extension position which is measured using the calliper or measuring device.	20 minutes