Pulmonary Aspiration of Gastric Contents
Conditions
Keywords
cricoid pressure
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 1. By electronic medical grade weighing scale 2. By sensor system electronically
Interventions
DEVICECricoid force sensor monitor system
Comprise of a sensor and a monitor system
DEVICESham Cricoid force sensor monitor system
Comprise of a sensor and a sham monitor system
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy status
Exclusion criteria
* Pregnant state * History of problems/ surgery to neck or spine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Force applied (Newton) within targeted range | 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 | Each application of cricoid pressure of 60 seconds | Measurement with electronic weighing system and force sensor system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeatability of force applied | Minimum 2 weeks apart | Measurement with electronic weighing system and cricoid force sensor system |
| Consistency in measurements between cricoid force system and electronic wee | Each application of cricoid pressure of 60 seconds | Difference in Measurement with electronic weighing system and cricoid force sensor system |
| User performance over time | Each application of cricoid pressure of 60 seconds | Cricoid force achieved with time during cricoid force application |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability evaluation of cricoid force sensor system | 1 day | Usability questionnaire |
Countries
Singapore
Outcome results
None listed