Difficult IntubationULOCNCT03178318
Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position
A study testing ultrasound in people with Difficult Intubation, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2017to 21 Jun 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
Who cannot join
- Age <18 years
- Inability to communicate or refuses consent
- History of problems with neck movement
- Arthritis of the neck
- Upper limb neurology
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northampton General Hospital NHS Trust
Northampton, NN1 5BD
About this study
Official title: An Observational Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position
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.
Read the detailed 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.
- Conditions
- Difficult Intubation
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
ultrasound of the neck to identify the position of upper and lower border of the cricothyroid membrane.
| Study group | Role | What they receive |
|---|---|---|
| cricothyroid membrane | Other | ultrasound of the neck will identify the position of the upper and lower border of the cricothyroid membrane in extended position. Receives: Procedure: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start19 Jun 2017
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy volunteers
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northampton General Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr C Frerk, Northampton General Hospital NHS Trust
- Investigators
- Chris Frerk, Principal investigator, Professor of Difficult Airways Society & Consultant Anaesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178318
- Sponsor's protocol ID
- 226475
- Acronym
- ULOC
- Status last verified
- Jan 2018
- First submitted
- 1 Jun 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21447488American 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.
PubMed 12717151Campbell 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.
PubMed 25844061Lamb 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.
PubMed 25637060Frerk 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 26556848Hochman 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.
PubMed 10453776Kim 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.
PubMed 21354999
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position
- ClinicalTrials.gov ID
- NCT03178318
- Acronym / sponsor ID
- ULOC / 226475
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northampton General Hospital NHS TrustUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 6 Jun 2017 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| cricothyroid membrane | Other | Procedure: ultrasoundultrasound of the neck will identify the position of the upper and lower border of the cricothyroid membrane in extended position. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
Key exclusion criteria (5 listed)
- Age <18 years
- Inability to communicate or refuses consent
- History of problems with neck movement
- Arthritis of the neck
- Upper limb neurology
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 |
|---|---|---|
| ultrasoundultrasound of the neck to identify the position of upper and lower border of the cricothyroid membrane. | Procedure or surgery | cricothyroid membrane |
Primary outcome
Ultrasound measurement
Time frame: 20 minutes
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.
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 Jan 2018.
- Results publication: 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.
- Results publication: PubMed 12717151American 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.
- Results publication: PubMed 25844061Campbell 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.
- Results publication: PubMed 25637060Lamb 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.
- Results publication: 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.
- Results publication: PubMed 10453776Hochman 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.
- Results publication: PubMed 21354999Kim 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.
- Individual participant dataSharing planned: No
Related trials for Difficult Intubation
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
RecruitingObservational study
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Awake Fiberoptic Intubation, Difficult Airway
Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
Difficult Intubation, Obesity
Not yet recruitingObservational study
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
Difficult Airway, Intubation, Intratracheal
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.
Chris Frerk principal investigator
Professor of Difficult Airways Society & Consultant Anaesthetist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Difficult Intubation, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
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 5 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 Jan 2018. 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 United Kingdom. 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?
Ultrasound measurement (time frame: 20 minutes). 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 NCT03178318, which also lists 7 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 Jan 2018; AzTrials last refreshed its copy on 2 Nov 2026.