Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540625
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
We 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 compressiontension 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 dimensions16 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None