Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers

Pulmonary aspiration of gastric contents is a leading cause of anesthesia-related morbidity and mortality, particularly in emergency surgeries and among patients who are not appropriately fasted prior to airway intervention. The application of cricoid pressure (CP), also known as the "Sellick maneuver" is the current clinical practice to prevent aspiration of gastric content during Rapid-sequence induction (RSI) of general anesthesia. This conventional CP uses manual pressure over the cricoid cartilage during RSI procedure for patients at high risk of aspiration. Since its incorporation into clinical practice, the utility and technique of CP have garnered considerable debate, mainly due to the inability to standardize the magnitude and consistency of the applied force. Too little force may be ineffective at preventing regurgitation and excessive force may impede ventilation and actually worsen laryngoscopy views, making intubation more difficult.

A significant challenge in current clinical practice of CP is the inconsistency in the force applied, which often falls short of the necessary intensity and duration. To address this issue, we developed a groundbreaking handheld device capable of monitoring applied pressure in real-time, aiding providers in delivering precise and reproducible CP. Furthermore, our device utilizes sensor fabrication technology, integrating microelectronic systems and microprocessors to measure and display force in real-time, all while remaining portable. However, before implementation in clinical practice, rigorous testing through human volunteer studies and subsequent clinical trials is imperative. Hence, this study aims to validate the efficacy of our novel CP device in helping Providers apply the accurate target force.

Study Overview

• Status: Not yet recruiting
• Conditions: Cricoid Pressure
• Intervention / Treatment: Device: the use of CP device application on human subjects.

Detailed Description

The investigators have developed a clinically robust, customizable, handheld device that incorporates a micro load cell (a sensor to measure force) and Arduino processor (a small circuit board) in order to apply accurate and reproducible CP. The novel device contains a compression/tension micro load cell (model: TAS520-5kg HT Sensor Technology Co. Ltd.) that is incorporated into a 3D printed CP application system (Figure 1). The 3D printed cricoid neck pad is designed based on average cricoid cartilage dimensions.16 The device is designed for testing forces in the range of 0-5 kg (~50 N). The load cell system is then attached to an Arduino circuit board, HX711 load cell amplification circuit and LCD digital display that are all encased in a 3D printed enclosure. The device has a microdisc port for internal memory that allows transfer of data for further backup and analysis. The device uses a rechargeable battery for ease of use and portability. The Force (N) is displayed on the LCD screen to give the user the exact force being applied in real time.

• Study Type: Observational
• Enrollment (Estimated): 63

Contacts and Locations

• Study Contact: Name: Emad A Al Azazi, MD; Phone Number: 2508 4166035800; Email: emad.al-azazi@uhn.ca
• Study Contact Backup: Name: Emad A Al Azazi; Phone Number: 2508 4166035800; Email: emad.al-azazi@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• Participants Participants will include staff volunteers from the Department of Anesthesia at two participating hospitals. A recruitment email will be distributed by the site study Research Coordinator to the department staff including research staff, administrative staff, anesthesia staff, anesthesia assistants, fellows, residents, and nurses.
• Providers Providers will include volunteers from perioperative staff consisting of operating room nurses, anesthesia staff, anesthesia assistants, fellows and residents who perform CP during RSI at the participating hospital. Perioperative staff who have previously applied CP or received training in CP will be included in this study.

Description

Inclusion Criteria:

• Anesthesia department staff Volunteers Participants
• Perioperative staff Volunteers Providers

Exclusion Criteria:

• Participants with skin problems, such as eczema or psoriasis
• Participants who is pregnant
• Participants with a history of neck or throat injury or anatomical abnormality

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess whether the Providers can use the CP device with an accurate target force and maintain the force in an acceptable range over one minute.	We set a target of 10N force for the study, with an acceptable range of 10N ± 2N.	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the device based on feedback from both Participants and Providers	Proportion of Providers who think CP device will be useful in clinical practice	one day
Effectiveness of the video training based on feedback from Providers	Proportion of Providers who think the video training was useful	One day

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Michael Dinsmore, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 4991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No