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Clinical Trials/NCT02749175
NCT02749175CompletedNot Applicable

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

KK Women's and Children's Hospital2 sites in 1 country22 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
22
Locations
2
Primary Endpoint
Force applied (Newton) within targeted range

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy status

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Cricoid force sensor monitor system (Device)

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

Intervention: Sham Cricoid force sensor monitor system (Device)

Current standard

No Intervention

Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
KK Women's and Children's Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Hee Hwan Ing

Senior consultant

KK Women's and Children's Hospital

Study Sites (2)

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