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

Trial Summary

What is the purpose of this trial?

Examining the effectiveness of cricoid pressure using ultrasound imaging. Pulmonary aspiration of gastric contents during tracheal intubation, although rare in pediatrics, is a potentially catastrophic complication of anesthesia. Cricoid pressure is applied during rapid sequence induction to occlude the esophagus and prevent aspiration of gastric contents. Accumulating evidence in adults suggests that cricoid pressure often is not effective, either because the esophagus normally lies lateral to the cricoid cartilage, or because downward pressure on the cricoid cartilage laterally displaces (rather than compresses) the esophagus. The investigator proposes to examine the effectiveness of cricoid pressure in children in the peri-operative setting using non-invasive ultrasound imaging. Using this approach, the investigator will investigate the normal anatomical relationship of the esophagus and the cricoid cartilage, as well as how cricoid pressures influences this relationship. Further, the investigator will examine whether alternatives to downward cricoid pressure, such as laterally directed pressure, are more effective at occluding the esophagus.

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 data supports the effectiveness of the treatment for preventing aspiration?

The 'BURP' maneuver can improve the view of the larynx (voice box) during intubation for experienced anesthesiologists, which may help in managing difficult airways. However, the combination of BURP with cricoid pressure might worsen the view, and there is variability in how cricoid pressure is applied, which can affect its effectiveness. ^{1 2 3 4 5}

Is cricoid pressure generally safe for humans?

The safety of cricoid pressure, also known as the Sellick maneuver, has been questioned due to variability in how it is applied by healthcare providers, which can lead to misapplication. However, it is a standard procedure used to reduce the risk of aspiration during anesthesia, suggesting it is generally considered safe when applied correctly. ^{1 3 4 6 7}

How does the treatment of cricoid pressure differ from other treatments for preventing aspiration?

Cricoid pressure is unique because it involves applying pressure to the cricoid cartilage to compress the esophagus and prevent stomach contents from entering the lungs during anesthesia. Unlike other treatments, it is a manual technique that requires specific training to ensure proper application and effectiveness. ^{1 6 8 9 10}

Research Team

David Kantor, MD, PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Variable application and misapplication of cricoid pressure. [2011]

2. Japan pubmed.ncbi.nlm.nih.gov

[The efficacy of the "BURP" maneuver during laryngoscopy and training period necessary for residents in anesthesiology]. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

[Survey of skills needed to assist tracheal intubation: nurse assistants lack accurate knowledge of BURP and cricoid pressure maneuvers]. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

The "BURP" maneuver worsens the glottic view when applied in combination with cricoid pressure. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. [2017]

6. Poland pubmed.ncbi.nlm.nih.gov

Measurement of cricoid pressure force during simulated Sellick's manoeuvre. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The efficacy of the "BURP" maneuver during a difficult laryngoscopy. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Training in application of cricoid pressure]. [2006]

9. Italy 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Cricoid pressure]. [2021]