Cricoid PressureNCT06540625
Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers
An observational study of Cricoid Pressure, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cricoid Pressure
- What is being tested?
- the use of CP device application on human subjects.
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Anesthesia department staff Volunteers Participants
- Perioperative staff Volunteers Providers
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Cricoid Pressure
- Being tested
- the use of CP device application on human subjects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (2)
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
Measured: one day
Effectiveness of the video training based on feedback from Providers
Proportion of Providers who think the video training was useful
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cricoid PressureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dinsmore, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540625
- Sponsor's protocol ID
- 4991
- Status last verified
- Dec 2024
- First submitted
- 2 Aug 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Handheld Device for Accurate Cricoid Pressure in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06540625
- Acronym / sponsor ID
- 4991
- Conditions
- Cricoid Pressure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Anesthesia department staff Volunteers Participants
- Perioperative staff Volunteers Providers
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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.
Time frame: one day
We set a target of 10N force for the study, with an acceptable range of 10N ± 2N.
2 secondary outcomes
Usability of the device based on feedback from both Participants and Providers
Time frame: one day
Effectiveness of the video training based on feedback from Providers
Time frame: One day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cricoid Pressure
Not yet recruiting
Effect of Left Paratracheal Pressure on Cerebral Oxygenation During General Anesthesia
Cerebral Oxygenation
Active, not recruiting
Sonographic Assessment of Cricoid Pressure
Aspiration; Gastric Contents, Anesthesia, Intubation Complication
Not yet recruiting
PARAtracheal vs CRIcoid Pressure on GLIttic DEformation (PARAGLIDE)
Airway Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Dinsmore, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Cricoid Pressure, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emad A Al Azazi, MD (4166035800 ext. 2508, emad.al-azazi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.