Airway ObstructionNCT03105037
The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females
An observational study of Airway Obstruction, run by The Rotunda Hospital at 1 site in Ireland.
Trial summary
Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Airway Obstruction
- How many people
- 64 participants
- Where
- 1 siteIreland
- Study dates
- 31 Jan 2017to 31 Mar 2017
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: women attending for routine gynaecological surgery
Who may be able to join
- Women attending for routine surgery
Who cannot join
- unable to give informed consent
- abnormal neck anatomy
- history of gastroesophageal reflux
- history of neck surgery or radiotherapy
- contraindication to supraglottic airway device insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females- a Prospective Observational Study.
Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients.
Consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. The accuracy of CTM identification by palpation will be evaluated using ultrasound.
Read the detailed description
Palpation of the airway structures results in misidentification of the cricothyroid membrane (CTM) in a high proportion of women. Female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. In obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the CTM by palpation in this population. Supraglottic airway device (SAD) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. The nature and clinical implication of SAD insertion on cricothyroidotomy remain unstudied.
Sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a SAD in situ (control and SAD assessments, within-subjects design). The patients are fasting women presenting for routine gynaecological surgery. Eight anaesthetists, at different levels of training, will perform eight individual CTM assessments with and without the SAD in situ.
Ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. Images are then downloaded, anonymised and randomised for blinded digital analysis.
- Conditions
- Airway Obstruction
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | CTM assessed with supraglottic airway in situ and without |
What is being measured
The primary outcome is the main question the study is designed to answer.
accurate identification of the cricothyroid membrane
accuracy of cricothyroid membrane identification, measured as either successful identification or unsuccessful (binary outcome). A successful identification is within 5mm of the midline and within the upper and lower borders of the cricothyroid membrane as measured using ultrasound.
Measured: At clinician assessment, on the day of patient recruitment.
Secondary outcomes (7)
Accurate identification of the midline of the neck
Accurate identification of the midline of the neck, binary outcome. A successful identification is within 5mm of the midline of the cricothyroid membrane as measured using ultrasound.
Measured: At clinician assessment, on the day of patient recruitment.
Difficulty of cricothyroid membrane assessment
Difficulty of assessing the cricothyroid membrane as graded subjectively by the clinician using a visual analogue scale (VAS) where '0' is the easiest possible assessment of the location of the cricothyroid membrane and '10' is the most difficult possible assessment of the location of the cricothyroid membrane.
Measured: At clinician assessment, on the day of patient recruitment.
Time taken to attempt localisation of the cricothyroid membrane
The time taken in seconds to attempt localisation of the cricothyroid membrane
Measured: At clinician assessment, on the day of patient recruitment.
Distance from clinician assessment to actual cricothyroid membrane location
The distance measured from the clinicians estimate of where the cricothyroid membrane is to where the actual location of the CTM is using ultrasound and measured in millimetres
Measured: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The distance from the skin to the first tracheal ring
The distance from the skin to the superficial surface of the first tracheal ring measured in millimetres using digital analysis of ultrasound images
Measured: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The distance from the skin to the cricoid cartilage
The distance from the skin to the superficial surface of the first tracheal ring measured in millimetres using digital analysis of ultrasound images
Measured: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The angle between the surface tissue interface of the cricothyroid membrane and the trachea
The angle between the surface tissue interface of the cricothyroid membrane and the trachea measured in degrees using digital analysis of ultrasound images
Measured: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start31 Jan 2017
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rotunda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Drew, The Rotunda Hospital
- Investigators
- Conan McCaul, Study director, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105037
- Sponsor's protocol ID
- REC-2017-001
- Status last verified
- Sep 2018
- First submitted
- 25 Mar 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females- a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03105037
- Acronym / sponsor ID
- REC-2017-001
- Conditions
- Airway Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Rotunda HospitalUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 7 Apr 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.
Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients.
Consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. The accuracy of CTM identification by palpation will be evaluated using ultrasound.
Detailed description
Palpation of the airway structures results in misidentification of the cricothyroid membrane (CTM) in a high proportion of women. Female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. In obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the CTM by palpation in this population. Supraglottic airway device (SAD) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. The nature and clinical implication of SAD insertion on cricothyroidotomy remain unstudied.
Sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a SAD in situ (control and SAD assessments, within-subjects design). The patients are fasting women presenting for routine gynaecological surgery. Eight anaesthetists, at different levels of training, will perform eight individual CTM assessments with and without the SAD in situ.
Ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. Images are then downloaded, anonymised and randomised for blinded digital analysis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –CTM assessed with supraglottic airway in situ and without |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women attending for routine gynaecological surgery
Key inclusion criteria (1 listed)
- Women attending for routine surgery
Key exclusion criteria (5 listed)
- unable to give informed consent
- abnormal neck anatomy
- history of gastroesophageal reflux
- history of neck surgery or radiotherapy
- contraindication to supraglottic airway device insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accurate identification of the cricothyroid membrane
Time frame: At clinician assessment, on the day of patient recruitment.
accuracy of cricothyroid membrane identification, measured as either successful identification or unsuccessful (binary outcome). A successful identification is within 5mm of the midline and within the upper and lower borders of the cricothyroid membrane as measured using ultrasound.
7 secondary outcomes
Accurate identification of the midline of the neck
Time frame: At clinician assessment, on the day of patient recruitment.
Difficulty of cricothyroid membrane assessment
Time frame: At clinician assessment, on the day of patient recruitment.
Time taken to attempt localisation of the cricothyroid membrane
Time frame: At clinician assessment, on the day of patient recruitment.
Distance from clinician assessment to actual cricothyroid membrane location
Time frame: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The distance from the skin to the first tracheal ring
Time frame: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The distance from the skin to the cricoid cartilage
Time frame: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
The angle between the surface tissue interface of the cricothyroid membrane and the trachea
Time frame: On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment
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 25 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Conan McCaul study director
Prof
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 Airway Obstruction, run by The Rotunda Hospital at 1 site in Ireland.
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 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 25 Sep 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 Ireland. 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?
accurate identification of the cricothyroid membrane (time frame: At clinician assessment, on the day of patient recruitment.). 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 25 Sep 2018.