Pulmonary Aspiration of Gastric ContentsNCT02749175
SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
A study testing Cricoid force sensor monitor system in people with Pulmonary Aspiration of Gastric Contents, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- What is being tested?
- Cricoid force sensor monitor system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status
Who cannot join
- Pregnant state
- History of problems/ surgery to neck or spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Ultrathin Miniature Force Sensor to Deliver Optimal Cricoid Pressure for Airway Protection in Patients at High Risk of Gastric Aspiration - a Verification of Design
Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI).
In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.
Read the detailed description
A total of 22 nurses or anesthetists will be recruited Inclusion criteria include healthy subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury
Cricoid pressure applied on manikin will be measured
- By electronic medical grade weighing scale
- By sensor system electronically
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Being tested
- Cricoid force sensor monitor system, Sham Cricoid force sensor monitor system
- Keywords
- cricoid pressure
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid force sensor monitor systemDevice
Comprise of a sensor and a monitor system
Sham Cricoid force sensor monitor systemDevice
Comprise of a sensor and a sham monitor system
| Study group | Role | What they receive |
|---|---|---|
| Cricoid force sensor monitor system | Experimental | Nurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons. Receives: Device: Cricoid force sensor monitor system |
| Sham cricoid force sensor monitor system | Sham comparator | Nurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons Receives: Device: Sham Cricoid force sensor monitor system |
| Current standard | No intervention | Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force applied (Newton) within targeted range
% target cricoid force achieved with and without using cricoid force sensor system
Measured: Each application of cricoid pressure of 60 seconds
Average force applied during application of 60 seconds
Measurement with electronic weighing system and force sensor system
Measured: Each application of cricoid pressure of 60 seconds
Secondary outcomes (3)
Repeatability of force applied
Measurement with electronic weighing system and cricoid force sensor system
Measured: Minimum 2 weeks apart
Consistency in measurements between cricoid force system and electronic wee
Difference in Measurement with electronic weighing system and cricoid force sensor system
Measured: Each application of cricoid pressure of 60 seconds
User performance over time
Cricoid force achieved with time during cricoid force application
Measured: Each application of cricoid pressure of 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start1 May 2016
- Primary completion30 Oct 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Aspiration of Gastric ContentsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hee Hwan Ing, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749175
- Sponsor's protocol ID
- KKWCH
- Status last verified
- May 2018
- First submitted
- 14 Apr 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Ultrathin Miniature Force Sensor to Deliver Optimal Cricoid Pressure for Airway Protection in Patients at High Risk of Gastric Aspiration - a Verification of Design
- ClinicalTrials.gov ID
- NCT02749175
- Acronym / sponsor ID
- KKWCH
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Keywords
- cricoid pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 May 2016
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI).
In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.
Detailed description
A total of 22 nurses or anesthetists will be recruited Inclusion criteria include healthy subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury
Cricoid pressure applied on manikin will be measured
- By electronic medical grade weighing scale
- By sensor system electronically
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cricoid force sensor monitor system | Experimental | Device: Cricoid force sensor monitor systemNurse applied cricoid pressure with a sensor guided by monitoring Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons. |
| Sham cricoid force sensor monitor system | Sham comparator | Device: Sham Cricoid force sensor monitor systemNurse applied pressure on a sham sensor with no monitor input. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons |
| Current standard | No intervention | –Nurse applied cricoid force according to memory. Nurses instructed to apply cricoid pressure at target force of 20-30 Newtons |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy status
Key exclusion criteria (2 listed)
- Pregnant state
- History of problems/ surgery to neck or spine.
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 |
|---|---|---|
| Cricoid force sensor monitor systemComprise of a sensor and a monitor system | Device | Cricoid force sensor monitor system |
| Sham Cricoid force sensor monitor systemComprise of a sensor and a sham monitor system | Device | Sham cricoid force sensor monitor system |
Primary outcome
Force applied (Newton) within targeted range
Time frame: Each application of cricoid pressure of 60 seconds
% target cricoid force achieved with and without using cricoid force sensor system
Average force applied during application of 60 seconds
Time frame: Each application of cricoid pressure of 60 seconds
Measurement with electronic weighing system and force sensor system
3 secondary outcomes
Repeatability of force applied
Time frame: Minimum 2 weeks apart
Consistency in measurements between cricoid force system and electronic wee
Time frame: Each application of cricoid pressure of 60 seconds
User performance over time
Time frame: Each application of cricoid pressure of 60 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Yes
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Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
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Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cricoid force sensor monitor system in people with Pulmonary Aspiration of Gastric Contents, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force applied (Newton) within targeted range (time frame: Each application of cricoid pressure of 60 seconds). The study lists 2 primary outcomes in all. 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 24 May 2018.