SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
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
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedMay 24, 2018
May 1, 2018
6 months
April 14, 2016
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Other Outcomes (1)
Usability evaluation of cricoid force sensor system
1 day
Study Arms (3)
Cricoid force sensor monitor system
EXPERIMENTALNurse 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 COMPARATORNurse 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 INTERVENTIONNurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Interventions
Comprise of a sensor and a monitor system
Comprise of a sensor and a sham monitor system
Eligibility Criteria
You may qualify if:
- \- Healthy status
You may not qualify if:
- Pregnant state
- History of problems/ surgery to neck or spine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KKWH
Singapore, 229899, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior consultant
Study Record Dates
First Submitted
April 14, 2016
First Posted
April 22, 2016
Study Start
May 1, 2016
Primary Completion
October 30, 2016
Study Completion
November 30, 2016
Last Updated
May 24, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share