SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment

Study Overview
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Brief Summary
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Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's educated hand that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI). In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.

Detailed Description
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A total of 22 nurses or anesthetists will be recruited Inclusion criteria include healthy subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury Cricoid pressure applied on manikin will be measured By electronic medical grade weighing scale By sensor system electronically

Official Title
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Novel Ultrathin Miniature Force Sensor to Deliver Optimal Cricoid Pressure for Airway Protection in Patients at High Risk of Gastric Aspiration - a Verification of Design

Conditions
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Pulmonary Aspiration of Gastric Contents

Intervention / Treatment
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* Device: Cricoid force sensor monitor system
* Device: Sham Cricoid force sensor monitor system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy status Exclusion Criteria: Pregnant state History of problems/ surgery to neck or spine.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cricoid force sensor monitor system<br>Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons. | Device: Cricoid force sensor monitor system<br>* Comprise of a sensor and a monitor system<br>|
| Sham Comparator: Sham cricoid force sensor monitor system<br>Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons | Device: Sham Cricoid force sensor monitor system<br>* Comprise of a sensor and a sham monitor system<br>|
| No Intervention: Current standard<br>Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force applied (Newton) within targeted range | % target cricoid force achieved with and without using cricoid force sensor system | Each application of cricoid pressure of 60 seconds | 
| Average force applied during application of 60 seconds | Measurement with electronic weighing system and force sensor system | Each application of cricoid pressure of 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of force applied | Measurement with electronic weighing system and cricoid force sensor system | Minimum 2 weeks apart | 
| Consistency in measurements between cricoid force system and electronic wee | Difference in Measurement with electronic weighing system and cricoid force sensor system | Each application of cricoid pressure of 60 seconds | 
| User performance over time | Cricoid force achieved with time during cricoid force application | Each application of cricoid pressure of 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cricoid pressure