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Clinical Trials/NCT04546087
NCT04546087
Completed
Not Applicable

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 site in 1 country50 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Complication of Anesthesia
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Enrollment
50
Locations
1
Primary Endpoint
Cricothyroid membrane position change
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
November 2, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Cricothyroid membrane size change(24 hours)

Study Sites (1)

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