Airway ObstructionNCT03656315
Scoring System to Predict Depth of Cricothyroid Membrane
A study testing Airway Assessment in people with Airway Obstruction, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
This study looks to devise a scoring system that can be used to predict difficult front of neck access due to increased depth of cricothyroid membrane. This study will recruit elective patients undergoing operations for a variety of procedures and correlate their measured (by ultrasound) cricothyroid depth with other… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Airway Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2018to 25 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective cases
Who cannot join
- Emergency cases
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Official title: Proposal for a Scoring System to Predict the Depth of Cricothyroid Membrane by Correlating Airway Assessment Parameters to the Depth of Cricothyroid Membrane
This study looks to devise a scoring system that can be used to predict difficult front of neck access due to increased depth of cricothyroid membrane. This study will recruit elective patients undergoing operations for a variety of procedures and correlate their measured (by ultrasound) cricothyroid depth with other difficult airway predictors (such as Mallampatti score).
Read the detailed description
A 'can't intubate can't oxygenate scenario (CICO) is defined as a situation when there is a failed intubation and failure to adequately oxygenate using facemask ventilation or supraglottic airway device resulting in increasing hypoxemia in an anaesthetised and paralysed patient. Although this situation is rare, if not managed appropriately it can result in hypoxic brain damage and death. The successful management of CICO includes timely decision making to perform front of neck access (FONA) via the cricothyroid membrane (CTM). The currently recommended technique in the UK is surgical cricothyroidotomy.
Successful FONA depends on the ease of anatomy of the neck and the ability to locate the cricothyroid membrane. In cases where the cricothyroid membrane is not palpable, front of neck access is difficult. The clinical procedure involves an 8 cm long skin incision and finger dissection to palpate the cricothyroid membrane. In a real-life situation, this will be compounded by profuse bleeding and no structure would be visible. Therefore, prediction of difficult FONA and appropriate preparation is essential for safe airway management.
Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.
DAS 2015 guideline recommend airway assessment and preparation for all patients presenting for surgery. Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.
- Conditions
- Airway Obstruction
- Being tested
- Airway Assessment
- Keywords
- Difficult airway, Cricothyroid membrane, Assessment
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway AssessmentOther
All patients recruited to this study will have an ultrasound of their cricothyroid membrane
| Study group | Role | What they receive |
|---|---|---|
| Airway assessment | Other | All patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed Receives: Other: Airway Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between difficult airway indicators and cricothyroid membrane
A positive correlation between airway assessment parameters and depth of the cricothyroid membrane
Measured: 20 minutes
Secondary outcomes (1)
A scoring system to predict the depth of cricotyroid membrane
A scoring system to predict the depth of the cricothyroid membrane using airway assessment parameters.
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 posted4 Sep 2018
- Study start14 Sep 2018
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All recruited participants will be included in the study
- Masking
- None (open label)
- Enrolment
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cyprican Mendonca, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656315
- Sponsor's protocol ID
- 247781
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2018
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for a Scoring System to Predict the Depth of Cricothyroid Membrane by Correlating Airway Assessment Parameters to the Depth of Cricothyroid Membrane
- ClinicalTrials.gov ID
- NCT03656315
- Acronym / sponsor ID
- 247781
- Conditions
- Airway Obstruction
- Keywords
- Difficult airway, Cricothyroid membrane, Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 4 Sep 2018 (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.
This study looks to devise a scoring system that can be used to predict difficult front of neck access due to increased depth of cricothyroid membrane. This study will recruit elective patients undergoing operations for a variety of procedures and correlate their measured (by ultrasound) cricothyroid depth with other difficult airway predictors (such as Mallampatti score).
Detailed description
A 'can't intubate can't oxygenate scenario (CICO) is defined as a situation when there is a failed intubation and failure to adequately oxygenate using facemask ventilation or supraglottic airway device resulting in increasing hypoxemia in an anaesthetised and paralysed patient. Although this situation is rare, if not managed appropriately it can result in hypoxic brain damage and death. The successful management of CICO includes timely decision making to perform front of neck access (FONA) via the cricothyroid membrane (CTM). The currently recommended technique in the UK is surgical cricothyroidotomy.
Successful FONA depends on the ease of anatomy of the neck and the ability to locate the cricothyroid membrane. In cases where the cricothyroid membrane is not palpable, front of neck access is difficult. The clinical procedure involves an 8 cm long skin incision and finger dissection to palpate the cricothyroid membrane. In a real-life situation, this will be compounded by profuse bleeding and no structure would be visible. Therefore, prediction of difficult FONA and appropriate preparation is essential for safe airway management.
Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.
DAS 2015 guideline recommend airway assessment and preparation for all patients presenting for surgery. Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All recruited participants will be included in the study
| Arm | Type | Receives |
|---|---|---|
| Airway assessment | Other | Other: Airway AssessmentAll patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cases
Key exclusion criteria (1 listed)
- Emergency cases
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 |
|---|---|---|
| Airway AssessmentAll patients recruited to this study will have an ultrasound of their cricothyroid membrane | Other | Airway assessment |
Primary outcome
Correlation between difficult airway indicators and cricothyroid membrane
Time frame: 20 minutes
A positive correlation between airway assessment parameters and depth of the cricothyroid membrane
1 secondary outcome
A scoring system to predict the depth of cricotyroid membrane
Time frame: 20 minutes
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 2 Nov 2022.
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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?
A study testing Airway Assessment in people with Airway Obstruction, run by University Hospitals Coventry and Warwickshire 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 1 inclusion and 1 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 2 Nov 2022. 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?
Correlation between difficult airway indicators and cricothyroid membrane (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.