Airway Complication of AnesthesiaNCT04546087
Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height
A study testing Ultrasound in people with Airway Complication of Anesthesia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 2 Nov 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >=18 years old
- Pregnant patients in third trimester (>28/40 weeks)
- Ability to understand the rationale of the study assessments and to provide signed consent.
Who cannot join
- Neck arthritis
- Cervical stenosis
- Known cervical degenerative disc disease
- Rheumatoid Arthritis
- Any restriction of neck movement
- Upper limb neurology
Show all 10Show fewer
- Patient refusal
- Patients not in established labour.
- Patients undergoing cesarean section
- Known distorted airway anatomy
Trial locations and contacts
1 site in 1 country.
About this study
The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Access through this membrane to provide oxygen and ventilation is critical in emergency situations where other traditional means to access the airway (e.g. through endotracheal ventilation, supraglottic airway devices or face mask ventilation) have failed. It is known, from previous studies, that due to the physiological changes that occur in labour, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult, specifically during the period of labor, delivery, and just after delivery. Ultrasound is becoming increasingly popular due to its ability both to identify the cricothyroid membrane and to improve success in accessing the airway through the cricothyroid membrane. What is not known, and has not been studied to date, is specifically how the anatomy (i.e. its height and its depth) specifically changes during the period of labour, delivery and just after delivery.
The aim of this study would be to scan (using ultrasound) pregnant women's necks once at the very start of their labour, and once within 4 hours of delivery of their baby, to identify how the size and depth of the cricothyroid membrane changes. This information would improve the understanding of how to best approach accessing this membrane in laboring pregnant women.
The investigators hypothesize that in labouring third trimester patient, that the depth to the cricothyroid membrane will increase, and there will be no change in the cricothyroid membrane height.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Ultrasound
- Keywords
- cricothyroid membrane, pregnancy, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound scan of the cricothyroid membrane
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound measurements of the cricothyroid membrane. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cricothyroid membrane position change
Difference between the depth from the skin to the cricothyroid membrane- tracheal interface change ultrasound between the onset of established labor and following delivery of the baby and placenta.
Measured: 24 hours
Secondary outcomes (1)
Cricothyroid membrane size change
Difference between the height of the cricothyroid membrane (CTM) at the onset of established labor and the height of CTM following delivery of the baby.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Sep 2020
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric You-Ten, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546087
- Sponsor's protocol ID
- 20-01
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casellato JF, Zasso FB, Wild E, Ye XY, Downey K, You-Ten E, Siddiqui N. Ultrasound assessment of cricothyroid membrane anatomy before and after labor: a prospective observational study. Int J Obstet Anesth. 2026 Feb;65:104802. doi: 10.1016/j.ijoa.2025.104802. Epub 2025 Oct 19.
PubMed 41138706
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height
- ClinicalTrials.gov ID
- NCT04546087
- Acronym / sponsor ID
- 20-01
- Conditions
- Airway Complication of Anesthesia
- Keywords
- cricothyroid membrane, pregnancy, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 11 Sep 2020 (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.
The cricothyroid membrane acts as a route through which the upper airway can be accessed to provide oxygen and ventilation to patients. Anesthesiologists need to deliver oxygen and ventilation to patients under general anesthesia, where patients may lose the ability to breath for themselves. Access through this membrane to provide oxygen and ventilation is critical in emergency situations where other traditional means to access the airway (e.g. through endotracheal ventilation, supraglottic airway devices or face mask ventilation) have failed. It is known, from previous studies, that due to the physiological changes that occur in labour, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult, specifically during the period of labor, delivery, and just after delivery. Ultrasound is becoming increasingly popular due to its ability both to identify the cricothyroid membrane and to improve success in accessing the airway through the cricothyroid membrane. What is not known, and has not been studied to date, is specifically how the anatomy (i.e. its height and its depth) specifically changes during the period of labour, delivery and just after delivery.
The aim of this study would be to scan (using ultrasound) pregnant women's necks once at the very start of their labour, and once within 4 hours of delivery of their baby, to identify how the size and depth of the cricothyroid membrane changes. This information would improve the understanding of how to best approach accessing this membrane in laboring pregnant women.
The investigators hypothesize that in labouring third trimester patient, that the depth to the cricothyroid membrane will increase, and there will be no change in the cricothyroid membrane height.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: UltrasoundUltrasound measurements of the cricothyroid membrane. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age >=18 years old
- Pregnant patients in third trimester (>28/40 weeks)
- Ability to understand the rationale of the study assessments and to provide signed consent.
Key exclusion criteria (10 listed)
- Neck arthritis
- Cervical stenosis
- Known cervical degenerative disc disease
- Rheumatoid Arthritis
- Any restriction of neck movement
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 scan of the cricothyroid membrane | Device | Ultrasound |
Primary outcome
Cricothyroid membrane position change
Time frame: 24 hours
Difference between the depth from the skin to the cricothyroid membrane- tracheal interface change ultrasound between the onset of established labor and following delivery of the baby and placenta.
1 secondary outcome
Cricothyroid membrane size change
Time frame: 24 hours
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 19 Mar 2024.
- Derived from this study: PubMed 41138706Casellato JF, Zasso FB, Wild E, Ye XY, Downey K, You-Ten E, Siddiqui N. Ultrasound assessment of cricothyroid membrane anatomy before and after labor: a prospective observational study. Int J Obstet Anesth. 2026 Feb;65:104802. doi: 10.1016/j.ijoa.2025.104802. Epub 2025 Oct 19.
- 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.
Eric You-Ten, MD principal investigator
MOUNT SINAI HOSPITAL
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 Airway Complication of Anesthesia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 3 inclusion and 10 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 19 Mar 2024. 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 position change (time frame: 24 hours). 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 NCT04546087, which also lists 1 linked publication.
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 19 Mar 2024.