Cricothyroid MembraneNCT04124770
Neck Position and Ultrasound Landmark of Cricothyroid Membrane
An observational study of Cricothyroid Membrane and Ultrasound, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cricothyroid Membrane, Ultrasound, Airway
- What is being tested?
- Movement
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2018to 9 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult volunteers over age 19
Who may be able to join
- Patients aged between 19 and 90
- Scheduled for elective surgeries
Who cannot join
- 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
Show all 9Show fewer
- history of cervical instrumentation
- history of neck deformities (acquired or congenital)
- history of allergic reactions to adhesive tapes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cricothyroid Membrane, Ultrasound, Airway, Cricothyroidotomy
- Being tested
- Movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MovementOther
Re-positioning of neck
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 months
Secondary outcomes (1)
Directionality of cricothyroid membrane movement measured by ultrasound
Directionality of the movement of the CTM during neck positions in relation to the sternal notch
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start9 Nov 2018
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cricothyroid MembraneStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Prabhakar, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124770
- Sponsor's protocol ID
- H18-01601
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participants data.
Publications
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.
PubMed 26556848Law 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.
PubMed 24132408Aslani 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.
PubMed 22366848Lamb 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.
Katz JA. 4th National Audit Project of the Royal College of Anaesthetists and The Difficult Airway Society. Anesthesiology. 2012. doi:10.1097/ALN.0b013e31823cf122.
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.
PubMed 20645953Bair 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.
PubMed 26198864Cook 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.
PubMed 21447488Kristensen 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.
PubMed 27037981Mallin 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.
PubMed 24475485
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ultrasound-guided Skin Markings of the Cricothyroid Membrane in Three Different Neck Positions: a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT04124770
- Acronym / sponsor ID
- H18-01601
- Conditions
- Cricothyroid Membrane, Ultrasound, Airway, Cricothyroidotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers over age 19
Key inclusion criteria (2 listed)
- Patients aged between 19 and 90
- Scheduled for elective surgeries
Key exclusion criteria (9 listed)
- history of cricothyrotomy
- history of tracheostomy
- history of thyroidectomy
- history of plastic surgery or neck skin flaps
- history of neck lymph node dissections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MovementRe-positioning of neck | Other | – |
Primary outcome
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
1 secondary outcome
Directionality of cricothyroid membrane movement measured by ultrasound
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Background: PubMed 26556848Frerk 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.
- Background: PubMed 24132408Law 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.
- Background: PubMed 22366848Aslani 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.
- BackgroundLamb 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.
- BackgroundKatz JA. 4th National Audit Project of the Royal College of Anaesthetists and The Difficult Airway Society. Anesthesiology. 2012. doi:10.1097/ALN.0b013e31823cf122.
- Background: PubMed 20645953Elliott 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.
- Background: PubMed 26198864Bair 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.
- Background: PubMed 21447488Cook 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.
- Background: PubMed 27037981Kristensen 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.
- Background: PubMed 24475485Mallin 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participants data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cricothyroid Membrane and Ultrasound, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cricothyroid membrane movement measured with ultrasound (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124770, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.