Assessing cricoid pressure effectiveness in children using ultrasound
Sonographic Assessment of Cricoid Pressure
This study is testing if applying pressure to the throat during intubation can help prevent stomach contents from entering the lungs in children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04190524 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of cricoid pressure applied during tracheal intubation in children, utilizing ultrasound imaging to assess the anatomical relationship between the esophagus and cricoid cartilage. The intervention involves applying cricoid pressure and left lateral paratracheal pressure to intubated or sedated children in the operating room or medical surgical intensive care unit. The study aims to determine how these pressures influence the position of the esophagus and whether they can effectively prevent aspiration of gastric contents. Patients will be recruited in person, and their esophageal position will be evaluated before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 17 years who are scheduled for surgery or admitted to the medical surgical intensive care unit while sedated.
Not a fit: Patients with a history of airway or esophageal malformations or known difficult airways may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of pediatric anesthesia by improving methods to prevent aspiration during intubation.
How similar studies have performed: While there is accumulating evidence regarding the ineffectiveness of cricoid pressure in adults, this specific approach in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David Kantor, MD, PhD — Boston Children's Hospital
- Study coordinator: David Kantor, MD, PhD
- Email: david.kantor@childrens.harvard.edu
- Phone: 617.355.7327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.