NCT03178318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2 days

First QC Date

June 1, 2017

Last Update Submit

January 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

cricothyroid membrane

OTHER

ultrasound of the neck will identify the position of the upper and lower border of the cricothyroid membrane in extended position.

Procedure: ultrasound

Interventions

ultrasoundPROCEDURE

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

cricothyroid membrane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.

You may not qualify if:

  • Age \<18 years
  • Inability to communicate or refuses consent
  • History of problems with neck movement
  • Arthritis of the neck
  • Upper limb neurology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northampton General Hospital NHS Trust

Northampton, NN1 5BD, United Kingdom

Location

Related Publications (7)

  • 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 Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

  • 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 Airway. Anesthesiology. 2003 May;98(5):1269-77. doi: 10.1097/00000542-200305000-00032. No abstract available.

  • 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.

  • 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. Epub 2015 Jan 31.

  • 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 intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

  • 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. doi: 10.1177/000348949910800801.

  • 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.

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Chris Frerk

    Professor of Difficult Airways Society & Consultant Anaesthetist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Healthy volunteers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 6, 2017

Study Start

June 19, 2017

Primary Completion

June 21, 2017

Study Completion

June 21, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations