Clinical trial NCT02749175: SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Aspiration of Gastric Contents
Keywords: cricoid pressure
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-22
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

- Healthy status

Exclusion Criteria:

* Pregnant state
* History of problems/ surgery to neck or spine.

Primary outcomes:
measure: Force applied (Newton) within targeted range
timeFrame: Each application of cricoid pressure of 60 seconds
measure: Average force applied during application of 60 seconds
timeFrame: Each application of cricoid pressure of 60 seconds
Secondary outcomes:
measure: Repeatability of force applied
timeFrame: Minimum 2 weeks apart
measure: Consistency in measurements between cricoid force system and electronic wee
timeFrame: Each application of cricoid pressure of 60 seconds
measure: User performance over time
timeFrame: Each application of cricoid pressure of 60 seconds
Other outcomes:
measure: Usability evaluation of cricoid force sensor system
timeFrame: 1 day
Locations:
city: Singapore
country: Singapore
facility: KKWH
Study officials:
References: