Sonographic Assessment of Cricoid Pressure

NCT04190524 | Active Not Recruiting

• 1 other identifier: IRB-P00033746
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Intubation Complication; Aspiration; Gastric Contents, Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in esophagus outer diameter following cricoid pressure

  1. To sonographically assess the diameter of the esophagus before and after application of conventional cricoid pressure 2. To sonographically asses the diameter of the esophagus before and after application of left lateral paralaryngeal pressure

  20 minutes

Study Arms (1)

Intervention/Control

OTHER

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.

Other: Application of cricoid pressure; Other: Application of Left lateral paratracheal pressure

Interventions

Application of cricoid pressure OTHER

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).

Intervention/Control

Application of Left lateral paratracheal pressure OTHER

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).

Intervention/Control

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients age 0 - 17 years who are on the OR (operating room) schedule and all patients admitted to the MSICU (Medical Surgical Intensive Care Unit) will be screened for this study.
• Patients in the MSICU will only be included if they are sedated as part of their clinical management.

You may not qualify if:

• history of airway or esophageal malformations (e.g. esophageal atresia or trachea-esophageal fistula) or who have had prior surgical procedures involving the airway or esophagus
• known difficult airways
• patients with tenuous artificial airways as determined by reviewing the CXR (chest x-ray)
• patients with abnormal blood flow pattern to the head (e.g. history of right carotid ligation or interruption, known incomplete circle of Willis, known right IJ (internal jugular) venous clots or obstruction
• patients with left neck CVLs (Central Venous Line)
• patients with compromised skin integrity on neck

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• David Kantor, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Physician

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: March 11, 2020
• Primary Completion: November 13, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)