Aspiration; Gastric Contents, AnesthesiaNCT04190524
Sonographic Assessment of Cricoid Pressure
A study testing Application of cricoid pressure and Application of Left lateral paratracheal pressure in people with Aspiration; Gastric Contents, Anesthesia and Intubation Complication, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Aspiration; Gastric Contents, Anesthesia, Intubation Complication
- What is being tested?
- Application of cricoid pressure and Application of Left lateral paratracheal pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
- Design and methods
- Study design This study is interventional study of intubated or sedated children who are in the operating room or admitted to the MSICU (Medical Surgical Intensive Care Unit). The intervention is the application of cricoid pressure and also left lateral paratracheal pressure. The outer diameter and position of the esophagus will be assessed sonographically before and after the intervention is performed. Patients and families will be recruited in person either in the pre-op clinic or in the MSICU.
- Patient selection and inclusion/exclusion criteria All patients age 0 - 17 years who are on the OR (operating room) schedule and all patients admitted to the MSICU 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: 1) 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, 2) known difficult airways, 3) patients with tenuous artificial airways as determined by reviewing the CXR (chest x-ray), 4) 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 venous clots or obstruction, 5) patients with left neck CVLs (central venous line), and 6) patients with compromised skin integrity on neck.
- Description of study treatments or exposures/predictors The primary physician/surgeon for each patient will be approached for permission to approach the family for consent. For operative patients, the study intervention will be performed following completion of the procedure when the patient is emerging from anesthesia. This is a period of time that often lasts 10s of minutes, has very good pain control, and is asleep. Scanning will be performed when the patient is intubated, to identify landmarks, and then as soon as the patient has been extubated to assess for the effect of cricoid or paratracheal pressure. For patients in the MSICU, the study intervention will be performed on any sedated patient who fulfills inclusion and exclusion criteria. 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). 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).
- Definition of primary and secondary outcomes/endpoints The primary outcome is a change in esophagus outer diameter following the intervention. The diameter will be assessed in the AP(anteroposterior) plane. In addition, the investigator will also record whether the esophageal mucosa is apposed following the application of pressure. Finally, the investigator will record the position of the esophagus relative to the airway before and after the intervention.
- Data collection methods, assessments, interventions and schedule Data will be collected at the time of ultrasound and uploaded to a secure REDCap database. Patient specific information will be collected, including age, gender, height, weight, primary diagnosis, and size of endotracheal tube. It is possible that additional covariates may be collected post hoc as necessary to complete analysis.
- Study timeline Data collection will proceed until the sample size is achieved. Interim data analysis will occur when 50% of the proposed sample size has been achieved.
- Being tested
- Application of cricoid pressure, Application of Left lateral paratracheal pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of cricoid pressureOther
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).
Application of Left lateral paratracheal pressureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Application of cricoid pressure; Other: Application of Left lateral paratracheal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in esophagus outer diameter following cricoid pressure
- To sonographically assess the diameter of the esophagus before and after application of conventional cricoid pressure
- To sonographically asses the diameter of the esophagus before and after application of left lateral paralaryngeal pressure
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start11 Mar 2020
- Primary completion13 Nov 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration; Gastric Contents, AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kantor, Boston Children's Hospital
- Investigators
- David Kantor, MD, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190524
- Sponsor's protocol ID
- IRB-P00033746
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Cricoid Pressure
- ClinicalTrials.gov ID
- NCT04190524
- Acronym / sponsor ID
- IRB-P00033746
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Design and methods
- Study design This study is interventional study of intubated or sedated children who are in the operating room or admitted to the MSICU (Medical Surgical Intensive Care Unit). The intervention is the application of cricoid pressure and also left lateral paratracheal pressure. The outer diameter and position of the esophagus will be assessed sonographically before and after the intervention is performed. Patients and families will be recruited in person either in the pre-op clinic or in the MSICU.
- Patient selection and inclusion/exclusion criteria All patients age 0 - 17 years who are on the OR (operating room) schedule and all patients admitted to the MSICU 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: 1) 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, 2) known difficult airways, 3) patients with tenuous artificial airways as determined by reviewing the CXR (chest x-ray), 4) 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 venous clots or obstruction, 5) patients with left neck CVLs (central venous line), and 6) patients with compromised skin integrity on neck.
- Description of study treatments or exposures/predictors The primary physician/surgeon for each patient will be approached for permission to approach the family for consent. For operative patients, the study intervention will be performed following completion of the procedure when the patient is emerging from anesthesia. This is a period of time that often lasts 10s of minutes, has very good pain control, and is asleep. Scanning will be performed when the patient is intubated, to identify landmarks, and then as soon as the patient has been extubated to assess for the effect of cricoid or paratracheal pressure. For patients in the MSICU, the study intervention will be performed on any sedated patient who fulfills inclusion and exclusion criteria. 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). 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).
- Definition of primary and secondary outcomes/endpoints The primary outcome is a change in esophagus outer diameter following the intervention. The diameter will be assessed in the AP(anteroposterior) plane. In addition, the investigator will also record whether the esophageal mucosa is apposed following the application of pressure. Finally, the investigator will record the position of the esophagus relative to the airway before and after the intervention.
- Data collection methods, assessments, interventions and schedule Data will be collected at the time of ultrasound and uploaded to a secure REDCap database. Patient specific information will be collected, including age, gender, height, weight, primary diagnosis, and size of endotracheal tube. It is possible that additional covariates may be collected post hoc as necessary to complete analysis.
- Study timeline Data collection will proceed until the sample size is achieved. Interim data analysis will occur when 50% of the proposed sample size has been achieved.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/Control | Other | Other: Application of cricoid pressure, Other: Application of Left lateral paratracheal pressureEach 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 may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of cricoid pressureThe 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 | Intervention/Control |
| Application of Left lateral paratracheal pressureNext, 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). | Other | Intervention/Control |
Primary outcome
Change in esophagus outer diameter following cricoid pressure
Time frame: 20 minutes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kantor, MD, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of cricoid pressure and Application of Left lateral paratracheal pressure in people with Aspiration; Gastric Contents, Anesthesia and Intubation Complication, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in esophagus outer diameter following cricoid pressure (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.