SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
Primary Purpose
Pulmonary Aspiration of Gastric Contents
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Cricoid force sensor monitor system
Sham Cricoid force sensor monitor system
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Aspiration of Gastric Contents focused on measuring cricoid pressure
Eligibility Criteria
Inclusion Criteria:
- Healthy status
Exclusion Criteria:
- Pregnant state
- History of problems/ surgery to neck or spine.
Sites / Locations
- KKWH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Cricoid force sensor monitor system
Sham cricoid force sensor monitor system
Current standard
Arm Description
Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons.
Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Outcomes
Primary Outcome Measures
Force applied (Newton) within targeted range
% target cricoid force achieved with and without using cricoid force sensor system
Average force applied during application of 60 seconds
Measurement with electronic weighing system and force sensor system
Secondary Outcome Measures
Repeatability of force applied
Measurement with electronic weighing system and cricoid force sensor system
Consistency in measurements between cricoid force system and electronic wee
Difference in Measurement with electronic weighing system and cricoid force sensor system
User performance over time
Cricoid force achieved with time during cricoid force application
Full Information
NCT ID
NCT02749175
First Posted
April 14, 2016
Last Updated
May 23, 2018
Sponsor
KK Women's and Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02749175
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (undefined)
Primary Completion Date
October 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Aspiration of Gastric Contents
Keywords
cricoid pressure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cricoid force sensor monitor system
Arm Type
Experimental
Arm Description
Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons.
Arm Title
Sham cricoid force sensor monitor system
Arm Type
Sham Comparator
Arm Description
Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Arm Title
Current standard
Arm Type
No Intervention
Arm Description
Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Intervention Type
Device
Intervention Name(s)
Cricoid force sensor monitor system
Intervention Description
Comprise of a sensor and a monitor system
Intervention Type
Device
Intervention Name(s)
Sham Cricoid force sensor monitor system
Intervention Description
Comprise of a sensor and a sham monitor system
Primary Outcome Measure Information:
Title
Force applied (Newton) within targeted range
Description
% target cricoid force achieved with and without using cricoid force sensor system
Time Frame
Each application of cricoid pressure of 60 seconds
Title
Average force applied during application of 60 seconds
Description
Measurement with electronic weighing system and force sensor system
Time Frame
Each application of cricoid pressure of 60 seconds
Secondary Outcome Measure Information:
Title
Repeatability of force applied
Description
Measurement with electronic weighing system and cricoid force sensor system
Time Frame
Minimum 2 weeks apart
Title
Consistency in measurements between cricoid force system and electronic wee
Description
Difference in Measurement with electronic weighing system and cricoid force sensor system
Time Frame
Each application of cricoid pressure of 60 seconds
Title
User performance over time
Description
Cricoid force achieved with time during cricoid force application
Time Frame
Each application of cricoid pressure of 60 seconds
Other Pre-specified Outcome Measures:
Title
Usability evaluation of cricoid force sensor system
Description
Usability questionnaire
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Healthy status
Exclusion Criteria:
Pregnant state
History of problems/ surgery to neck or spine.
Facility Information:
Facility Name
KKWH
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
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