Airway Complication of AnesthesiaNCT04569539
The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.
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 (CTM) is situated in the anterior neck and may be readily palpated in most people. In the event of difficulties securing the airway during a general anesthetic the CTM can facilitate emergency access to the upper airway to allow rescue oxygenation and ventilation. 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2020to 7 Jan 2024
- 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
- Pregnant patients in third trimester (>28/40 weeks)
- Morbid Obesity (BMI≥40kg/m2)
- Ability to understand the rationale of the study assessments and to provide signed consent - Ability to safely and comfortably take part in the study protocol
Who cannot join
- Non pregnant patients
- Pregnant patients less than 28 weeks pregnant
- Not Morbidly Obese (BMI≥40kg/m2)
- Cervical spine pathology causing restricted neck movement or neurological compromise - Previous neck surgery or irradiation
- Upper limb neurology
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
The cricothyroid membrane (CTM) is situated in the anterior neck and may be readily palpated in most people. In the event of difficulties securing the airway during a general anesthetic the CTM can facilitate emergency access to the upper airway to allow rescue oxygenation and ventilation. Caesarean sections are today carried out using either a spinal or epidural anaesthesia and for good reason. Due to physiological effects of pregnancy a patient's airway is known to be more challenging when pregnant than outside of pregnancy. The pregnant airway can even change over the course of labor. Airway ultrasound has become increasingly popular and allows accurate identification of airway structures including the cricothyroid membrane. It has already shown to be more accurate than palpation alone in identifying the cricothyroid membrane in obese pregnant women. The incidence of obesity in pregnancy continues to increase. Although regional anesthesia is preferred when these women require Caesarean section this is not always possible or successful. Use of a device to optimise patient position for airway management is the standard of practice for obese pregnant patients. These devices are known as head elevating laryngoscopy position pillows, the TROOP elevation pillow ® is one such device. However, the investigators do not know if and how positioning the obese pregnant patient on a TROOP elevation pillow ® affects position, depth and height of the cricothyroid membrane. The investigators want to know if the TROOP elevation pillow ® will hinder or facilitate the performance of a surgical airway in the event of failed airway management in the pregnant obese patient.
The investigators hypothesize that in pregnant obese patients in the third trimester use of the TROOP elevation pillow ® will change the position, height and depth of the CTM compared to the neutral position. Based on previous evidence the investigators believe the position of the membrane will move superiorly in relation to the sternal notch, will increase in height and the depth from the skin to the membrane will be reduced. The investigators also hypothesize that CTM identification and marking prior to final patient positioning may be misleading.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Ultrasound
- Keywords
- cricothyroid membrane, pregnancy, obesity, ultrasound
- Medical subject headings
- Obesity
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.
The change in the CTM midpoint between neutral positioning and the head elevated position.
The head will be elevated using the TROOP elevating pillow ®.
Measured: 10 min
Secondary outcomes (3)
The change in depth of the CTM between neutral positioning and the head elevated.
The head will be elevated using the TROOP elevating pillow ®.
Measured: 10 min
The change in height of the CTM between neutral positioning and the head elevated.
The head will be elevated using the TROOP elevating pillow ®.
Measured: 10 min
The change in distance from the sternal notch to the CTM mid-point between neutral positioning and the head elevated.
The head will be elevated using the TROOP elevating pillow ®.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start24 Sep 2020
- Primary completion7 Jan 2024
- Study completion7 Jan 2024
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naveed Siddiqui, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569539
- Sponsor's protocol ID
- 20-02
- Status last verified
- Feb 2024
- First submitted
- 24 Sep 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zasso F, Spring A, Casellato JF, Wild E, You-Ten E, Carvalho JCA, Morales J, Downey K, Ye XY, Siddiqui N. Head elevating device and cricothyroid membrane position in pregnant women with obesity class 3: an observational study. Int J Obstet Anesth. 2025 Aug;63:104680. doi: 10.1016/j.ijoa.2025.104680. Epub 2025 May 8.
PubMed 40451049
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.
- ClinicalTrials.gov ID
- NCT04569539
- Acronym / sponsor ID
- 20-02
- Conditions
- Airway Complication of Anesthesia
- Keywords
- cricothyroid membrane, pregnancy, obesity, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 7 Jan 2024 (actual)
- First posted
- 30 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 (CTM) is situated in the anterior neck and may be readily palpated in most people. In the event of difficulties securing the airway during a general anesthetic the CTM can facilitate emergency access to the upper airway to allow rescue oxygenation and ventilation. Caesarean sections are today carried out using either a spinal or epidural anaesthesia and for good reason. Due to physiological effects of pregnancy a patient's airway is known to be more challenging when pregnant than outside of pregnancy. The pregnant airway can even change over the course of labor. Airway ultrasound has become increasingly popular and allows accurate identification of airway structures including the cricothyroid membrane. It has already shown to be more accurate than palpation alone in identifying the cricothyroid membrane in obese pregnant women. The incidence of obesity in pregnancy continues to increase. Although regional anesthesia is preferred when these women require Caesarean section this is not always possible or successful. Use of a device to optimise patient position for airway management is the standard of practice for obese pregnant patients. These devices are known as head elevating laryngoscopy position pillows, the TROOP elevation pillow ® is one such device. However, the investigators do not know if and how positioning the obese pregnant patient on a TROOP elevation pillow ® affects position, depth and height of the cricothyroid membrane. The investigators want to know if the TROOP elevation pillow ® will hinder or facilitate the performance of a surgical airway in the event of failed airway management in the pregnant obese patient.
The investigators hypothesize that in pregnant obese patients in the third trimester use of the TROOP elevation pillow ® will change the position, height and depth of the CTM compared to the neutral position. Based on previous evidence the investigators believe the position of the membrane will move superiorly in relation to the sternal notch, will increase in height and the depth from the skin to the membrane will be reduced. The investigators also hypothesize that CTM identification and marking prior to final patient positioning may be misleading.
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)
- Pregnant patients in third trimester (>28/40 weeks)
- Morbid Obesity (BMI≥40kg/m2)
- Ability to understand the rationale of the study assessments and to provide signed consent - Ability to safely and comfortably take part in the study protocol
Key exclusion criteria (6 listed)
- Non pregnant patients
- Pregnant patients less than 28 weeks pregnant
- Not Morbidly Obese (BMI≥40kg/m2)
- Cervical spine pathology causing restricted neck movement or neurological compromise - Previous neck surgery or irradiation
- 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 scan of the cricothyroid membrane | Device | Ultrasound |
Primary outcome
The change in the CTM midpoint between neutral positioning and the head elevated position.
Time frame: 10 min
The head will be elevated using the TROOP elevating pillow ®.
3 secondary outcomes
The change in depth of the CTM between neutral positioning and the head elevated.
Time frame: 10 min
The change in height of the CTM between neutral positioning and the head elevated.
Time frame: 10 min
The change in distance from the sternal notch to the CTM mid-point between neutral positioning and the head elevated.
Time frame: 10 min
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 7 Mar 2024.
- Derived from this study: PubMed 40451049Zasso F, Spring A, Casellato JF, Wild E, You-Ten E, Carvalho JCA, Morales J, Downey K, Ye XY, Siddiqui N. Head elevating device and cricothyroid membrane position in pregnant women with obesity class 3: an observational study. Int J Obstet Anesth. 2025 Aug;63:104680. doi: 10.1016/j.ijoa.2025.104680. Epub 2025 May 8.
- 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.
Naveed Siddiqui, 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 6 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 7 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?
The change in the CTM midpoint between neutral positioning and the head elevated position. (time frame: 10 min). 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 NCT04569539, 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 7 Mar 2024.