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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Force applied (Newton) within targeted range
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy status
Exclusion Criteria
- •Pregnant state
- •History of problems/ surgery to neck or spine.
Arms & Interventions
Cricoid force sensor monitor system
Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons.
Intervention: Cricoid force sensor monitor system (Device)
Sham cricoid force sensor monitor system
Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Intervention: Sham Cricoid force sensor monitor system (Device)
Current standard
Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Outcomes
Primary Outcomes
Force applied (Newton) within targeted range
Time Frame: Each application of cricoid pressure of 60 seconds
% target cricoid force achieved with and without using cricoid force sensor system
Average force applied during application of 60 seconds
Time Frame: Each application of cricoid pressure of 60 seconds
Measurement with electronic weighing system and force sensor system
Secondary Outcomes
- Repeatability of force applied(Minimum 2 weeks apart)
- Consistency in measurements between cricoid force system and electronic wee(Each application of cricoid pressure of 60 seconds)
- User performance over time(Each application of cricoid pressure of 60 seconds)
Investigators
Hee Hwan Ing
Senior consultant
KK Women's and Children's Hospital
