Scoring System to Predict Depth of Cricothyroid Membrane
Primary Purpose
Airway Obstruction
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Airway Assessment
Sponsored by
About this trial
This is an interventional screening trial for Airway Obstruction focused on measuring Difficult airway, Cricothyroid membrane, Assessment
Eligibility Criteria
Inclusion Criteria:
- Elective cases
Exclusion Criteria:
- Emergency cases
Sites / Locations
- University Hospitals Coventry & Warwickshire NHS Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Airway assessment
Arm Description
All patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed
Outcomes
Primary Outcome Measures
Correlation between difficult airway indicators and cricothyroid membrane
A positive correlation between airway assessment parameters and depth of the cricothyroid membrane
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03656315
First Posted
August 15, 2018
Last Updated
October 31, 2022
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03656315
Brief Title
Scoring System to Predict Depth of Cricothyroid Membrane
Official Title
Proposal for a Scoring System to Predict the Depth of Cricothyroid Membrane by Correlating Airway Assessment Parameters to the Depth of Cricothyroid Membrane
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
Difficult airway, Cricothyroid membrane, Assessment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All recruited participants will be included in the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
2600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Airway assessment
Arm Type
Other
Arm Description
All patients recruited will be entered into this arm of the study. Airway assessment including Ultrasound scan will be performed
Intervention Type
Other
Intervention Name(s)
Airway Assessment
Intervention Description
All patients recruited to this study will have an ultrasound of their cricothyroid membrane
Primary Outcome Measure Information:
Title
Correlation between difficult airway indicators and cricothyroid membrane
Description
A positive correlation between airway assessment parameters and depth of the cricothyroid membrane
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
A scoring system to predict the depth of cricotyroid membrane
Description
A scoring system to predict the depth of the cricothyroid membrane using airway assessment parameters.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Elective cases
Exclusion Criteria:
Emergency cases
Facility Information:
Facility Name
University Hospitals Coventry & Warwickshire NHS Trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
12. IPD Sharing Statement
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Scoring System to Predict Depth of Cricothyroid Membrane
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