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临床试验/NCT02749175
NCT02749175已完成不适用

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 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Force applied (Newton) within targeted range

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy status

排除标准

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

研究组 & 干预措施

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.

干预措施: 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

干预措施: 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

结局指标

主要结局

Force applied (Newton) within targeted range

时间窗: 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

时间窗: Each application of cricoid pressure of 60 seconds

Measurement with electronic weighing system and force sensor system

次要结局

  • 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)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hee Hwan Ing

Senior consultant

KK Women's and Children's Hospital

研究点 (2)

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