SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment

May 23, 2018 updated by: Hee Hwan Ing, KK Women's and Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KKWH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Healthy status

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cricoid force sensor monitor system
Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons.
Device: Cricoid force sensor monitor system
Comprise of a sensor and a monitor system
Sham Comparator: Sham cricoid force sensor monitor system
Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons
Device: Sham Cricoid force sensor monitor system
Comprise of a sensor and a sham monitor system
No Intervention: Current standard
Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force applied (Newton) within targeted range
Time Frame: Each application of cricoid pressure of 60 seconds
% 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
Time Frame: Each application of cricoid pressure of 60 seconds
Measurement with electronic weighing system and force sensor system
Each application of cricoid pressure of 60 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability of force applied
Time Frame: Minimum 2 weeks apart
Measurement with electronic weighing system and cricoid force sensor system
Minimum 2 weeks apart
Consistency in measurements between cricoid force system and electronic wee
Time Frame: Each application of cricoid pressure of 60 seconds
Difference in Measurement with electronic weighing system and cricoid force sensor system
Each application of cricoid pressure of 60 seconds
User performance over time
Time Frame: Each application of cricoid pressure of 60 seconds
Cricoid force achieved with time during cricoid force application
Each application of cricoid pressure of 60 seconds

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability evaluation of cricoid force sensor system
Time Frame: 1 day
Usability questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKWCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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