Scoring System to Predict Depth of Cricothyroid Membrane

Proposal for a Scoring System to Predict the Depth of Cricothyroid Membrane by Correlating Airway Assessment Parameters to the Depth of Cricothyroid Membrane

This study looks to devise a scoring system that can be used to predict difficult front of neck access due to increased depth of cricothyroid membrane. This study will recruit elective patients undergoing operations for a variety of procedures and correlate their measured (by ultrasound) cricothyroid depth with other difficult airway predictors (such as Mallampatti score).

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Other: Airway Assessment

Detailed Description

A 'can't intubate can't oxygenate scenario (CICO) is defined as a situation when there is a failed intubation and failure to adequately oxygenate using facemask ventilation or supraglottic airway device resulting in increasing hypoxemia in an anaesthetised and paralysed patient. Although this situation is rare, if not managed appropriately it can result in hypoxic brain damage and death. The successful management of CICO includes timely decision making to perform front of neck access (FONA) via the cricothyroid membrane (CTM). The currently recommended technique in the UK is surgical cricothyroidotomy.

Successful FONA depends on the ease of anatomy of the neck and the ability to locate the cricothyroid membrane. In cases where the cricothyroid membrane is not palpable, front of neck access is difficult. The clinical procedure involves an 8 cm long skin incision and finger dissection to palpate the cricothyroid membrane. In a real-life situation, this will be compounded by profuse bleeding and no structure would be visible. Therefore, prediction of difficult FONA and appropriate preparation is essential for safe airway management.

Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.

DAS 2015 guideline recommend airway assessment and preparation for all patients presenting for surgery. Routine airway assessment includes mouth opening measured as inter-incisor gap, Mallampatti score, thyromental distance, sternomental distance, jaw protrusion and neck movements. In addition, ability to perform front of neck access should be ascertained prior to induction of general anaesthesia. Depth of cricothyroid membrane is one of the factors leading to technical difficulties in front of neck access. In situations where the CTM is deep and not palpable, FONA is technically difficult and takes longer. A previous observational study has shown a positive correlation between patient's weight, height, body mass index and neck circumference with depth of cricothyroid membrane. A scoring system to assess the depth of cricothyroid membrane based on the patient's height, weight, neck circumference and other airway assessment parameters would be useful in predicting the depth of CTM. Hence difficulties with front of neck access can be anticipated and appropriate measures can be taken in the event a CICO situation arises.

• Study Type: Interventional
• Enrollment (Actual): 2600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospitals Coventry & Warwickshire NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective cases

Exclusion Criteria:

• Emergency cases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Airway assessment; All patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed	Other: Airway Assessment; All patients recruited to this study will have an ultrasound of their cricothyroid membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between difficult airway indicators and cricothyroid membrane	A positive correlation between airway assessment parameters and depth of the cricothyroid membrane	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A scoring system to predict the depth of cricotyroid membrane	A scoring system to predict the depth of the cricothyroid membrane using airway assessment parameters.	20 minutes

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Assessment; Difficult airway; Cricothyroid membrane
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 247781

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No