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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cricoid force sensor monitor system | Experimental | Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons. |
|
| Sham cricoid force sensor monitor system | Sham Comparator | Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons |
|
| Current standard | No Intervention | Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cricoid force sensor monitor system | Device | Comprise of a sensor and a monitor system |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability evaluation of cricoid force sensor system | Usability questionnaire | 1 day |
Inclusion Criteria:
- Healthy status
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KKWH | Singapore | 229899 | Singapore |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 27, 2019 | |
| Reset | Dec 18, 2019 | |
| Release | Feb 20, 2020 |
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| Sham Cricoid force sensor monitor system | Device | Comprise of a sensor and a sham monitor system |
|
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 |
| Reset | Mar 4, 2020 |
| Release | Sep 16, 2020 |
| Reset | Oct 8, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 27, 2019 | Dec 18, 2019 | |||
| Feb 20, 2020 | Mar 4, 2020 | |||
| Sep 16, 2020 | Oct 8, 2020 |
| ID | Term |
|---|---|
| D063466 | Respiratory Aspiration of Gastric Contents |
| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D053120 | Respiratory Aspiration |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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