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Sonographic Assessment of Cricoid Pressure

NCT04190524 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Aspiration; Gastric Contents, Anesthesia
  • Intubation Complication

Interventions

OTHER

Application 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).

OTHER

Application 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).

Sponsors & Collaborators

Principal Investigators

  • David Kantor, MD, PhD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2024-11-13
Completion
2027-09-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190524 on ClinicalTrials.gov