Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height

Airway Complication of Anesthesia Clinical Trial

Official title:

Impact of Labor and Delivery on Ultrasound Measured Cricothyroid Membrane Depth and Height

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546087
• Other study ID #: 20-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 2, 2022

Study information

• Verified date: March 2024
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Neck arthritis

• Cervical stenosis

• Known cervical degenerative disc disease

• Rheumatoid Arthritis

• Any restriction of neck movement

• Upper limb neurology

• Patient refusal

• Patients not in established labour.

• Patients undergoing cesarean section

• Known distorted airway anatomy

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Device:
• Ultrasound
Ultrasound scan of the cricothyroid membrane

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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.	24 hours