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

NCT06540625 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2024-12-11

No results posted yet for this study

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

Interventions

DEVICE

the use of CP device application on human subjects.

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Michael Dinsmore, MD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-04-01
Completion
2025-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540625 on ClinicalTrials.gov