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

NCT04546087 | Completed

• 1 other identifier: 20-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Complication of Anesthesia

Keywords

cricothyroid membrane; pregnancy; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cricothyroid membrane size change

  24 hours

Study Arms (1)

Ultrasound

EXPERIMENTAL

Ultrasound measurements of the cricothyroid membrane.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasound scan of the cricothyroid membrane

Ultrasound

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eric You-Ten, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 11, 2020
• Study Start: September 1, 2020
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)