NCT04124770

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 10, 2019

Last Update Submit

October 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cricothyroid membrane movement measured with ultrasound

    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 Outcomes (1)

  • Directionality of cricothyroid membrane movement measured by ultrasound

    14 months

Interventions

Re-positioning of neck

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult volunteers over age 19

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (10)

  • 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.

    PMID: 26556848BACKGROUND
  • Law JA, Broemling N, Cooper RM, Drolet P, Duggan LV, Griesdale DE, Hung OR, Jones PM, Kovacs G, Massey S, Morris IR, Mullen T, Murphy MF, Preston R, Naik VN, Scott J, Stacey S, Turkstra TP, Wong DT; Canadian Airway Focus Group. The difficult airway with recommendations for management--part 2--the anticipated difficult airway. Can J Anaesth. 2013 Nov;60(11):1119-38. doi: 10.1007/s12630-013-0020-x. Epub 2013 Oct 17.

    PMID: 24132408BACKGROUND
  • Aslani A, Ng SC, Hurley M, McCarthy KF, McNicholas M, McCaul CL. Accuracy of identification of the cricothyroid membrane in female subjects using palpation: an observational study. Anesth Analg. 2012 May;114(5):987-92. doi: 10.1213/ANE.0b013e31824970ba. Epub 2012 Feb 24.

    PMID: 22366848BACKGROUND
  • Lamb A, Zhang J, Hung O, et al. Exactitude du repérage de la membrane cricothyroïdienne par des stagiaires et des patrons en anesthésie dans un établissement canadien. Can J Anesth. 2015. doi:10.1007/s12630-015-0326-y.

    BACKGROUND
  • Katz JA. 4th National Audit Project of the Royal College of Anaesthetists and The Difficult Airway Society. Anesthesiology. 2012. doi:10.1097/ALN.0b013e31823cf122.

    BACKGROUND
  • Elliott DS, Baker PA, Scott MR, Birch CW, Thompson JM. Accuracy of surface landmark identification for cannula cricothyroidotomy. Anaesthesia. 2010 Sep;65(9):889-94. doi: 10.1111/j.1365-2044.2010.06425.x.

    PMID: 20645953BACKGROUND
  • Bair AE, Chima R. The inaccuracy of using landmark techniques for cricothyroid membrane identification: a comparison of three techniques. Acad Emerg Med. 2015 Aug;22(8):908-14. doi: 10.1111/acem.12732. Epub 2015 Jul 21.

    PMID: 26198864BACKGROUND
  • 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.

    PMID: 21447488BACKGROUND
  • Kristensen MS, Teoh WH, Rudolph SS, Hesselfeldt R, Borglum J, Tvede MF. A randomised cross-over comparison of the transverse and longitudinal techniques for ultrasound-guided identification of the cricothyroid membrane in morbidly obese subjects. Anaesthesia. 2016 Jun;71(6):675-83. doi: 10.1111/anae.13465. Epub 2016 Apr 2.

    PMID: 27037981BACKGROUND
  • Mallin M, Curtis K, Dawson M, Ockerse P, Ahern M. Accuracy of ultrasound-guided marking of the cricothyroid membrane before simulated failed intubation. Am J Emerg Med. 2014 Jan;32(1):61-3. doi: 10.1016/j.ajem.2013.07.004.

    PMID: 24475485BACKGROUND

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, University of British Columbia

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 11, 2019

Study Start

November 9, 2018

Primary Completion

October 9, 2019

Study Completion

October 9, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participants data.

Locations