Cricoid Pressure for Preventing Aspiration

Overseen By Ivy Pham, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Airway malformations, Difficult airways, Abnormal blood flow, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of cricoid pressure in preventing the inhalation of stomach contents during anesthesia in children. Researchers will use ultrasound imaging to determine whether pressing on the cricoid cartilage (a ring of cartilage around the windpipe) effectively blocks the esophagus or merely displaces it. The trial will also assess whether applying pressure sideways (known as Left lateral paratracheal pressure) more effectively blocks the esophagus. It seeks children scheduled for surgery or in the ICU who are sedated, excluding those with specific airway or esophagus issues or neck skin problems. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially enhance safety measures for children undergoing anesthesia.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this technique is safe for preventing aspiration in children?

Research has shown that cricoid pressure is often used to prevent food from entering the lungs during anesthesia. However, it can sometimes cause the vocal cords to close, posing a risk. Less than 5% of people using the standard method of cricoid pressure succeeded, while over 90% succeeded with a new technique. This indicates that while cricoid pressure can work, it might not always be effective.

Studies have found that left lateral paratracheal pressure is just as effective as cricoid pressure for some procedures. Both methods have similar success rates for placing breathing devices on the first try.

In summary, both methods are generally well-tolerated and show promise. However, the success of cricoid pressure depends on its application. Evidence supports that left lateral paratracheal pressure works as well as traditional methods. Always consult a healthcare provider before joining a trial to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether applying cricoid pressure or left lateral paratracheal pressure can help prevent aspiration by affecting the esophagus's diameter. Unlike traditional methods that rely on different techniques to manage airway protection, this approach directly measures changes in the esophagus with these specific pressures. By understanding how these pressures alter esophageal diameter, the trial could pave the way for more effective and immediate interventions to prevent aspiration during medical procedures.

What evidence suggests that cricoid pressure is effective for preventing aspiration in children?

Research has shown that applying cricoid pressure can prevent stomach contents from being inhaled into the lungs during rapid intubation. However, some studies suggest it might not always be effective because the esophagus can shift to the side instead of being compressed. One study found that cricoid pressure effectively blocked the esophagus, even when a tube was inserted through the nose into the stomach. This trial will compare cricoid pressure with left lateral paratracheal pressure, which has been shown to be equally effective for some airway procedures. Both methods have their advantages, and ongoing research is investigating which is better at preventing the inhalation of stomach contents during anesthesia. ^{1 2 3 4 6}

Who Is on the Research Team?

David Kantor, MD, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 0-17 years who are scheduled for surgery or admitted to the Medical Surgical Intensive Care Unit (MSICU) and require sedation. It's not suitable for those outside this age range or not in these specific hospital settings.

Inclusion Criteria

I am in the medical ICU and sedated as part of my treatment.

I am 17 years old or younger and scheduled for surgery or admitted to the intensive care unit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Application of cricoid pressure and left lateral paratracheal pressure with ultrasound imaging to assess esophagus diameter

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Application of cricoid pressure
• Application of Left lateral paratracheal pressure

Trial Overview The study is testing how effective cricoid pressure is at preventing aspiration during tracheal intubation, using ultrasound imaging. It compares traditional downward pressure with a side-pressure technique to see which better prevents stomach contents from entering the lungs.

How Is the Trial Designed?

Group I: Intervention/Control Experimental Treatment 2 Interventions

Each subject will serve as their own control. The esophagus diameter will be measured on each subject, then cricoid pressure will be applied and the esophagus diameter will again be measured.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study involving 43 patients undergoing elective surgery, the modified BURP maneuver combined with cricoid pressure actually worsened the laryngoscopic view in 30% of cases, indicating it may not be beneficial for improving visibility during intubation.

The application of cricoid pressure alone also worsened the view in 12.5% of cases, suggesting that routine use of these maneuvers during rapid sequence induction of anesthesia may not enhance safety or efficacy in intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "BURP" maneuver worsens the glottic view when applied in combination with cricoid pressure. Snider, DD., Clarke, D., Finucane, BT.[2022]

In a study observing 32 healthcare providers over 30 months, researchers found 10 different techniques of cricoid pressure being used, with the original three-finger Sellick technique rarely applied, indicating significant variability in practice.

Misapplication of cricoid pressure, including incorrect pressure on the thyroid cartilage and sternocleidomastoid muscles, raises concerns about potential patient harm, highlighting the need for standardized training in this critical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variable application and misapplication of cricoid pressure. Brisson, P., Brisson, M.[2011]

The 'BURP' maneuver significantly enhances laryngeal visualization during intubation, proving effective even for inexperienced anesthesiology residents, as shown in a study involving 132 patients.

Residents who had completed more than two months of training or had intubated 31-35 patients showed significantly better visualization skills compared to those with less experience, indicating that practice and training duration are crucial for skill development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of the "BURP" maneuver during laryngoscopy and training period necessary for residents in anesthesiology]. Onda, M., Inomata, S., Satsumae, T., et al.[2018]

In a study involving 34 anesthesia assistants, only 4 doctors and 5 nurses effectively applied the recommended cricoid pressure before training, highlighting a significant skill gap.

After training, while 13 doctors and 12 nurses could apply the pressure correctly, they were unable to retain this skill after one month, indicating the need for ongoing training to maintain proficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training in application of cricoid pressure]. Shimabukuro, A., Kawatani, M., Nagao, N., et al.[2006]

In a study involving 206 anaesthetists and nurses, only 49% correctly identified the cricoid cartilage when performing Sellick's manoeuvre, indicating a significant gap in knowledge about this critical procedure.

The majority of participants applied incorrect pressure during the manoeuvre, with only 16.5% using the right amount of force on the first attempt, highlighting the need for simulation training to improve the safety and efficacy of cricoid pressure application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of cricoid pressure force during simulated Sellick's manoeuvre. Andruszkiewicz, P., Zawadka, M., Kosińska, A., et al.[2019]

A survey of 40 nurses revealed significant confusion between the BURP maneuver and cricoid pressure (CP), with many incorrectly identifying the correct application techniques, which could hinder effective tracheal intubation.

Only a small number of nurses demonstrated correct knowledge and skills for these maneuvers, highlighting the need for ongoing education and training to ensure safe and effective use in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of skills needed to assist tracheal intubation: nurse assistants lack accurate knowledge of BURP and cricoid pressure maneuvers]. Taguchi, S., Kusunoki, S., Tanigawa, K., et al.[2010]

Cricoid pressure, commonly used by anaesthetists during rapid sequence induction to prevent regurgitation and pulmonary aspiration, lacks evidence supporting its effectiveness in reducing aspiration risk.

There are significant concerns regarding cricoid pressure, including its potential to interfere with airway management, leading to questions about its routine use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cricoid pressure]. Steinmann, D., Priebe, HJ.[2021]

In a study of 108 adult patients undergoing general anesthesia, left paratracheal pressure (LPP) was found to be non-inferior to cricoid pressure (CP) for the successful insertion of a laryngeal mask airway (LMA) on the first attempt, with a success rate of 68.5% for LPP compared to 51.9% for CP.

LPP not only showed a higher success rate but also made LMA insertion easier compared to CP, with no serious complications reported in either group, suggesting it may be a safer and more effective alternative during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left paratracheal pressure versus cricoid pressure for successful laryngeal mask airway insertion in adult patients: a randomized, non-inferiority trial. Hur, M., Lee, K., Min, SK., et al.[2021]

The study using MRI on 24 adult volunteers revealed that cricoid pressure (CP) compresses the hypopharynx, not the esophagus, which is crucial for understanding the mechanism of the Sellick maneuver in preventing gastric regurgitation.

With CP, the hypopharynx's diameter was reduced by 35%, indicating that this maneuver effectively compresses the alimentary tract, regardless of the lateral movement of the cricoid ring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Rice, MJ., Mancuso, AA., Gibbs, C., et al.[2017]

The BURP maneuver, which involves displacing the larynx in specific directions, significantly enhances the visualization of the larynx during laryngoscopy in patients without head and neck malformations, based on a study of 630 participants.

Compared to simple back pressure on the larynx, the BURP maneuver provides better visualization, making it a more effective technique for medical professionals during procedures requiring laryngeal examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of the "BURP" maneuver during a difficult laryngoscopy. Takahata, O., Kubota, M., Mamiya, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07004998

PARAtracheal vs CRIcoid Pressure on GLIttic DEformation ... This randomized crossover study evaluates the effects of left paratracheal pressure, cricoid pressure, and no pressure on glottic visualization ...

2. researchgate.net researchgate.net/publication/353667785_Left_paratracheal_pressure_versus_cricoid_pressure_for_successful_laryngeal_mask_airway_insertion_in_adult_patients_a_randomized_non-inferiority_trial?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Left paratracheal pressure versus cricoid ... 35 their results demonstrated 60% successful placement of the lMa with either method. in the corresponding editorial, sorbello and Zdravkovic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34337919/

Left paratracheal pressure versus cricoid ... This randomized clinical trial demonstrated the non-inferiority of LPP over CP in the success rate of LMA insertion on the first attempt in ...

4. semanticscholar.org semanticscholar.org/paper/Effectiveness-of-Cricoid-and-Paratracheal-Pressures-Kim-Chang/7b9b417a4fd7307e4692636870590952aa971f0e

Effectiveness of Cricoid and Paratracheal Pressures in ... The occlusion of the upper esophagus defined by inability to pass an esophageal stethoscope was more effective with cricoid pressure than with paratracheal ...

5. withpower.com withpower.com/trial/phase-respiratory-aspiration-of-gastric-contents-1-2021-7170b

Cricoid Pressure for Preventing Aspiration The 'BURP' maneuver significantly enhances laryngeal visualization during intubation, proving effective even for inexperienced anesthesiology residents, as ...

6. orbi.uliege.be orbi.uliege.be/bitstream/2268/332862/1/EJA-D-24-00734%20FINAL.pdf

SHORT SCIENTIFIC REPORT 7. Lastly, our study does not assess LPP safety in the case of gastric regurgitation against a closed oesophagus, nor its superiority compared with cricoid ...