Impact of Change of Head and Neck Position on Cricothyroid Membrane Localization and Membrane Height in Parturient Patients

NCT04138121 | Completed

• 1 other identifier: 19-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The cricothyroid membrane acts a route through which the upper airway can be accessed in order to provide oxygen and ventilation to patients. The need to provide oxygen and ventilation to patients is essential particularly under general anesthesia, where patients may lose the ability to breathe 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 that due to the physiological changes of pregnancy, the upper airway of the body undergoes changes that can make accessing the airway through traditional means more difficult. Ultrasound is becoming increasingly popular due to its ability to identify the cricothyroid membrane, to improve success in accessing the airway through the cricothyroid membrane. Studies to date in non pregnant adults have shown that alterations in the head and neck position can alter the position and size of the cricothyroid membrane. No study to date however has looked at how changing the position of the head and neck effects the position and size of the cricothyroid membrane in pregnant patients. It is important to study these changes in the pregnant population, given the physiological changes of pregnancy that make accessing the airway through traditional methods more difficult in non pregnant patients. The investigators hypothesize that in pregnant patients in the third trimester, that changing the head from the neutral to maximally extended neck position will alter the position of the cricothyroid membrane in relation to anatomical skin markings between positions. The investigators also hypothesize that in pregnant patients in the third trimester that changing the head from the neutral to maximally extended neck position will increase the size of the cricothyroid membrane. The investigatorsalso aim to determine at what position in the neck a theoretical standardized incision will allow access to the cricothyroid membrane.

Conditions

Airway Complication of Anesthesia

Keywords

cricothyroid membrane; pregnancy; ultrasound

Outcome Measures

Primary Outcomes (1)

• Cricothyroid membrane position change

  To measure the distance the center of the cricothyroid membrane changes position on ultrasound between neutral and maximal neck extension in third trimester patients.

  30 minutes

Secondary Outcomes (2)

• Cricothyroid membrane size change

  30 minutes

• Distance above sternal notch

  30 minutes

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+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Non pregnant patients
• Pregnant patients less than 28 weeks pregnant

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

• Naveed Siddiqui, 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: October 22, 2019
• First Posted: October 24, 2019
• Study Start: November 4, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)