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

NCT ID: NCT04546087

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-11-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ultrasound

Ultrasound measurements of the cricothyroid membrane.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

Ultrasound scan of the cricothyroid membrane

Interventions

Ultrasound

Ultrasound scan of the cricothyroid membrane

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric You-Ten, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20-01

Identifier Type: -

Identifier Source: org_study_id