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

NCT06540625 | Not Yet Recruiting

• 1 other identifier: 4991
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cricoid Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Usability of the device based on feedback from both Participants and Providers

  one day

• Effectiveness of the video training based on feedback from Providers

  One day

Interventions

the use of CP device application on human subjects. DEVICE

Trained providers will be asked to apply CP at 10N of force to the marked location using the cricoid applicator for one minute. Data relating to applied force across the whole one minute will be measured continuously and will be captured and stored. The CP device will have a microdisc port for internal memory and then the wifi on the board will transfer the information to a cloud server for backup and storage for redundancy. A threshold of 10 ± 2 N applied force will be set to define successful CP attempts. Participants must remain in this range for 95% of the trial time after the first five seconds have passed. At any point during the CP application, if the volunteer experiences pain, they can request that the pressure be stopped. However, we do not expect any pain with 10N, except for minor discomfort.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Anesthesia department staff Volunteers Participants
• Perioperative staff Volunteers Providers

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Officials

• Michael Dinsmore, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emad A Al Azazi, MD

CONTACT

4166035800; emad.al-azazi@uhn.ca

Emad A Al Azazi

CONTACT

4166035800; emad.al-azazi@uhn.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share