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

NCT ID: NCT02749175

Last Updated: 2018-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2016-11-30

Brief Summary

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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

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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

Conditions

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Pulmonary Aspiration of Gastric Contents

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cricoid force sensor monitor system

Intervention Type DEVICE

Comprise of a sensor and a monitor system

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

Group Type SHAM_COMPARATOR

Sham Cricoid force sensor monitor system

Intervention Type DEVICE

Comprise of a sensor and a sham monitor system

Current standard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cricoid force sensor monitor system

Comprise of a sensor and a monitor system

Intervention Type DEVICE

Sham Cricoid force sensor monitor system

Comprise of a sensor and a sham monitor system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Healthy status

Exclusion Criteria

* Pregnant state
* History of problems/ surgery to neck or spine.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hee Hwan Ing

Senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KKWH

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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KKWCH

Identifier Type: -

Identifier Source: org_study_id

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