Cricoid PressureNCT02161601
Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry.
A study testing Cricoid Pressure in people with Cricoid Pressure, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cricoid Pressure
- What is being tested?
- Cricoid Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery and Anesthesia with intubation,
- ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery)
- Body Mass Index > 18,5 and < 30
- Informed, signed and dated consent
Who cannot join
- Suspected difficult airway,
- Pharyngoesophageal dysfunction,
- Body Mass Index < 18,5 or > 30,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry
During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure.
Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.
- Conditions
- Cricoid Pressure
- Being tested
- Cricoid Pressure
- Keywords
- Cricoid pressure, Rapid Sequence Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cricoid PressureProcedure or surgery
Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea
| Study group | Role | What they receive |
|---|---|---|
| Correctly and incorrectly applied cricoid pressure | Experimental | Not described Receives: Procedure: Cricoid Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure
Measured: 15 sec. during ongoing cricoid pressure application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Pellrud, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161601
- Sponsor's protocol ID
- RAPESO-01
- Other IDs
- 2012/464
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry
- ClinicalTrials.gov ID
- NCT02161601
- Acronym / sponsor ID
- RAPESO-01
- Conditions
- Cricoid Pressure
- Keywords
- Cricoid pressure, Rapid Sequence Induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jun 2014 (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.
During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure.
Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correctly and incorrectly applied cricoid pressure | Experimental | Procedure: Cricoid Pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgery and Anesthesia with intubation,
- ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery)
- Body Mass Index > 18,5 and < 30
- Informed, signed and dated consent
Key exclusion criteria (3 listed)
- Suspected difficult airway,
- Pharyngoesophageal dysfunction,
- Body Mass Index < 18,5 or > 30,
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 PressureCorrect Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea | Procedure or surgery | Correctly and incorrectly applied cricoid pressure |
Primary outcome
difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure
Time frame: 15 sec. during ongoing cricoid pressure application
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 11 Jun 2014.
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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 Pressure in people with Cricoid Pressure, run by Örebro University, Sweden at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 11 Jun 2014. 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 Sweden. 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. 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?
difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure (time frame: 15 sec. during ongoing cricoid pressure application). 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 Jun 2014.