RecruitingNot ApplicableNCT04190524

Sonographic Assessment of Cricoid Pressure

Sponsor

Boston Children's Hospital

Enrollment

45 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Intubation Complication Aspiration; Gastric Contents, Anesthesia

Summary

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.

Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study uses ultrasound imaging to examine what happens to the airway and esophagus when cricoid pressure is applied during intubation. Cricoid pressure is a technique commonly used in emergency medicine and anesthesia — a nurse or assistant presses on the cartilage in the throat to prevent stomach contents from entering the lungs during intubation. While widely used, its effectiveness and safety are debated, and ultrasound provides a real-time way to see exactly what is happening to the airway structures. The study includes children under 17 years old who are either scheduled for an operating room procedure or sedated in the ICU. Ultrasound images are taken before, during, and after cricoid pressure to measure how the airway and esophagus respond. You may be eligible if... - Your child is under 17 years of age - Your child is scheduled for an operating room procedure, OR - Your child is admitted to the MSICU and is receiving sedation You may NOT be eligible if... - Your child has a history of airway or esophageal malformations (e.g., esophageal atresia) - Your child has a known difficult airway - Your child has abnormal blood flow to the head or a compromised airway device - Your child has wounds or compromised skin on the neck - Your child has a central venous line on the left side of the neck Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERApplication of cricoid pressure

The study first involves recording a baseline image of the neck anatomy using ultrasound, which is a non-invasive, non-irradiating, non-painful imaging modality. Once the baseline anatomy has been imaged, conventional cricoid pressure will be applied with fingers and/or with the ultrasound probe itself and an image will be recorded. The force applied to the cricoid cartilage will be 30 newtons, as determined by a thin force measurement sensor (Tekscan flexiforce sensor) placed in between the patient's skin and the finger (or ultrasound probe).

OTHERApplication of Left lateral paratracheal pressure

Next, left lateral paralaryngeal pressure will be applied at the level of the cricoid cartilage with fingers and/or the ultrasound probe itself, and the image will again be recorded. Left lateral paralaryngeal pressure will be 30 newtons, as determined by a thin force measurement sensor placed in between the patient's skin and the finger (or ultrasound probe).