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

Pulmonary Aspiration of Gastric Contents Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749175
• Other study ID #: KKWCH
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: May 2018
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 30, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy status

Exclusion Criteria:

• Pregnant state

• History of problems/ surgery to neck or spine.

Related Conditions & MeSH terms

• Pulmonary Aspiration of Gastric Contents
• Respiratory Aspiration of Gastric Contents

Intervention

Device:
• Cricoid force sensor monitor system
Comprise of a sensor and a monitor system
• Sham Cricoid force sensor monitor system
Comprise of a sensor and a sham monitor system

Locations

Country	Name	City	State
Singapore	KKWH	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability evaluation of cricoid force sensor system	Usability questionnaire	1 day
Primary	Force applied (Newton) within targeted range	% target cricoid force achieved with and without using cricoid force sensor system	Each application of cricoid pressure of 60 seconds
Primary	Average force applied during application of 60 seconds	Measurement with electronic weighing system and force sensor system	Each application of cricoid pressure of 60 seconds
Secondary	Repeatability of force applied	Measurement with electronic weighing system and cricoid force sensor system	Minimum 2 weeks apart
Secondary	Consistency in measurements between cricoid force system and electronic wee	Difference in Measurement with electronic weighing system and cricoid force sensor system	Each application of cricoid pressure of 60 seconds
Secondary	User performance over time	Cricoid force achieved with time during cricoid force application	Each application of cricoid pressure of 60 seconds