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Completed

NCT Number: NCT02749175

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy status

Exclusion criteria

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

Treatment and study plan

Cricoid force sensor monitor system

Device

Comprise of a sensor and a monitor system

Sham Cricoid force sensor monitor system

Device

Comprise of a sensor and a sham monitor system

Primary outcomes

  1. 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

  2. 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

  1. Repeatability of force applied

    Time frame: Minimum 2 weeks apart

    Measurement with electronic weighing system and cricoid force sensor system

  2. 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

  3. User performance over time

    Time frame: Each application of cricoid pressure of 60 seconds

    Cricoid force achieved with time during cricoid force application

Other outcomes

  1. Usability evaluation of cricoid force sensor system

    Time frame: 1 day

    Usability questionnaire

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2016
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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