CricothyroidotomyNCT01637207
How Easy is it to Identify the Cricothyroid Membrane in Children? Can Ultrasound Imagine be Used to Aid Identification?
A study testing Palpation and Ultrasound in people with Cricothyroidotomy, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The Investigators aim to determine how easy it is for anaesthetists to identify the Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in addition. The investigators aim to conduct a randomised single blinded trial to compare methods to detect the CTM. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Cricothyroidotomy
- What is being tested?
- Palpation and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Feb 2013
- 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 Up to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between 0-8 years requiring general anaethesia for elective MRI head, neck and spinal scans
Who cannot join
- Children with obvious neck deformity, goitre, tracheostomy and emergency cases
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Sick Children NHS Foundation Trust
London, WC1N 3JH
About this study
Official title: How Easy is it to Identify the Cricothyroid Membrane in Children? Can Ultrasound Imaging me Used to Aid Identification?
The Investigators aim to determine how easy it is for anaesthetists to identify the Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in addition. The investigators aim to conduct a randomised single blinded trial to compare methods to detect the CTM.
The first group of patients will be randomised to palpation of anatomical landmarks group. Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas.
The second group of patients will be randomised to receive ultrasound. Prior to commencing the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the two marked areas.
Read the detailed description
Cricothyroidotomy is an infrequent but potentially life-saving procedure. The need for cricothyroidotomy arises from the can't intubate and can't ventilate (CICV) scenario and is therefore incorporated in the difficult airway guidelines for both adults and children. This CICV scenario is less common in the paediatric population than in the adult population and most difficult airways can be managed with-bag mask ventilation and PEEP.
The cricothyroid membrane is a useful place to access the airway in the case of glottic or supraglottic obstruction as it is relatively avascular, superficial and the 'full ring' of the cricoid protects against posterior perforation. In adults, the average the cricothyroid membrane CTM is 13.7mm long and 12.4mm wide. The CTM is relatively short in children. In neonates the CTM has a mean height of 2.6mm and a width of 3mm.
In children the most prominent anterior midline structures in the neck are not the thyroid as in adults but the hyoid bone and cricoid cartilage. As the larynx is more cephalad in children the cricothyroid membrane is higher than in adults and placement of a catheter may be more difficult as the mandible gets in the way. A healthy amount of adipose in the subcutaneous tissue can obscure the anatomy. Currently clinicians identify the CTM using palpation of anatomical landmarks. In infants, with the head in extension and soft tissue pulled up towards the mandible, the CTM may be difficult to distinguish. It is suggested that bimanual manipulation may enable identification of the cartilaginous trachea.
To perform a cricothyroid puncture, a syringe containing sterile saline is attached to a cannula. The skin over the cricothyroid membrane is stabilised with the index finger and thumb of the non-dominant hand. The transtracheal cannula is inserted through the cricothyroid membrane at a 45º angle heading caudal and posterior. However, in neonates due to the restricted dimensions, a needle is the only option for cricothyroidotomy. Even in experienced hands, cricothyroidotomy is technically challenging. In inexperienced hands this can lead to significant injuries including the risk of fracture of the thyroid and cricoid cartilages.
A recent abstract has tried to determine whether how easy it is to locate the CTM in children. Their initial conclusions suggest that the identification of the CTM is difficult. The limitations of their study are that there are small numbers and only one person has been asked to perform the identification.
The applications of ultrasound are vast and varied. It is readily available, portable and easy to use. Of note, a recent study has used ultrasound (Sonosite 10Hz) to help identify the CTM in adults. Following a period of training, it was found to improve accuracy and speed of identification.
The investigators aim to determine how easy it is for anaesthetists to identify the CTM in children and infants and whether ultrasound maybe a useful adjunct. The investigators aim to conduct a randomized single blinded trial to compare methods to detect the CTM: palpation of anatomical landmarks versus ultrasound .
- Conditions
- Cricothyroidotomy
- Being tested
- Palpation, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalpationOther
Group A: Palpation Group
UltrasoundOther
Group B: Ultrasound Group
| Study group | Role | What they receive |
|---|---|---|
| palpation | Experimental | Not described Receives: Other: Palpation |
| ultrasound | Experimental | Not described Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of placement of the marker
Accuracy of the placement of the marker in relation to the cricithyroid membrane and trachea on MRI images.
Measured: 4-6 months
Secondary outcomes (1)
Time taken to identify CTM/Trachea
Time taken to identify CTM/Trachea placement confidence assessed using the VAS Score (0-100: impossible to very confident). Comparison between age groups 0-4 years Vs 4-8 years.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CricothyroidotomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Dobby, MBBS, Principal investigator, Great Ormond Street Hospital for Sick Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637207
- Sponsor's protocol ID
- 10AR11
- Status last verified
- Oct 2022
- First submitted
- 1 Jun 2012
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Easy is it to Identify the Cricothyroid Membrane in Children? Can Ultrasound Imaging me Used to Aid Identification?
- ClinicalTrials.gov ID
- NCT01637207
- Acronym / sponsor ID
- 10AR11
- Conditions
- Cricothyroidotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Jul 2012 (estimated)
- 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.
The Investigators aim to determine how easy it is for anaesthetists to identify the Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in addition. The investigators aim to conduct a randomised single blinded trial to compare methods to detect the CTM.
The first group of patients will be randomised to palpation of anatomical landmarks group. Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas.
The second group of patients will be randomised to receive ultrasound. Prior to commencing the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the two marked areas.
Detailed description
Cricothyroidotomy is an infrequent but potentially life-saving procedure. The need for cricothyroidotomy arises from the can't intubate and can't ventilate (CICV) scenario and is therefore incorporated in the difficult airway guidelines for both adults and children. This CICV scenario is less common in the paediatric population than in the adult population and most difficult airways can be managed with-bag mask ventilation and PEEP.
The cricothyroid membrane is a useful place to access the airway in the case of glottic or supraglottic obstruction as it is relatively avascular, superficial and the 'full ring' of the cricoid protects against posterior perforation. In adults, the average the cricothyroid membrane CTM is 13.7mm long and 12.4mm wide. The CTM is relatively short in children. In neonates the CTM has a mean height of 2.6mm and a width of 3mm.
In children the most prominent anterior midline structures in the neck are not the thyroid as in adults but the hyoid bone and cricoid cartilage. As the larynx is more cephalad in children the cricothyroid membrane is higher than in adults and placement of a catheter may be more difficult as the mandible gets in the way. A healthy amount of adipose in the subcutaneous tissue can obscure the anatomy. Currently clinicians identify the CTM using palpation of anatomical landmarks. In infants, with the head in extension and soft tissue pulled up towards the mandible, the CTM may be difficult to distinguish. It is suggested that bimanual manipulation may enable identification of the cartilaginous trachea.
To perform a cricothyroid puncture, a syringe containing sterile saline is attached to a cannula. The skin over the cricothyroid membrane is stabilised with the index finger and thumb of the non-dominant hand. The transtracheal cannula is inserted through the cricothyroid membrane at a 45º angle heading caudal and posterior. However, in neonates due to the restricted dimensions, a needle is the only option for cricothyroidotomy. Even in experienced hands, cricothyroidotomy is technically challenging. In inexperienced hands this can lead to significant injuries including the risk of fracture of the thyroid and cricoid cartilages.
A recent abstract has tried to determine whether how easy it is to locate the CTM in children. Their initial conclusions suggest that the identification of the CTM is difficult. The limitations of their study are that there are small numbers and only one person has been asked to perform the identification.
The applications of ultrasound are vast and varied. It is readily available, portable and easy to use. Of note, a recent study has used ultrasound (Sonosite 10Hz) to help identify the CTM in adults. Following a period of training, it was found to improve accuracy and speed of identification.
The investigators aim to determine how easy it is for anaesthetists to identify the CTM in children and infants and whether ultrasound maybe a useful adjunct. The investigators aim to conduct a randomized single blinded trial to compare methods to detect the CTM: palpation of anatomical landmarks versus ultrasound .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palpation | Experimental | Other: Palpation |
| ultrasound | Experimental | Other: Ultrasound |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between 0-8 years requiring general anaethesia for elective MRI head, neck and spinal scans
Key exclusion criteria (1 listed)
- Children with obvious neck deformity, goitre, tracheostomy and 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 |
|---|---|---|
| PalpationGroup A: Palpation Group | Other | palpation |
| UltrasoundGroup B: Ultrasound Group | Other | ultrasound |
Primary outcome
Accuracy of placement of the marker
Time frame: 4-6 months
Accuracy of the placement of the marker in relation to the cricithyroid membrane and trachea on MRI images.
1 secondary outcome
Time taken to identify CTM/Trachea
Time frame: 4-6 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 4 Oct 2022.
Related trials for Cricothyroidotomy
Not yet recruiting
Mental Rehearsal in Emergency Cricothyroidotomy Training
Difficult Airway, Medical Training
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.
Nadine Dobby, MBBS principal investigator
Great Ormond Street Hospital for Sick Children NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palpation and Ultrasound in people with Cricothyroidotomy, run by Great Ormond Street Hospital for Children NHS Foundation 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 4 Oct 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?
Accuracy of placement of the marker (time frame: 4-6 months). 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 4 Oct 2022.