Clinical trial NCT03520374: Bedside Ultrasound of Gastric Contents in Pediatric Populations
Official title: Evaluating the Effectiveness of a Self-instructional Ultrasound Training Program at Teaching Aspiration Risk Assessment Through Gastric Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Contents
Keywords: ultrasound
gastric contents
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Perioperative aspiration of gastric contents is a rare but serious adverse event. The risk of aspiration can be estimated by perioperative evaluation of stomach contents with ultrasound using a validated technique and scoring system. A lack of knowledge or familiarity is frequently cited by anesthesia providers as a rationale for not performing perioperative ultrasound assessments. The purpose of this study is to determine whether novice ultrasonography users (medical students, undergraduates, or inexperienced anesthesiologists) can be effectively taught a technique to evaluate stomach contents as compared to experts in ultrasonography.

Detailed description: This study will be conducted in two arms. For part 1, we will evaluate the efficacy of the self-taught course at producing accurate reads among novice ultrasound users on ideal, cooperative, adult subjects. For part 2, we will evaluate the effectiveness of the course through an identical study that uses clinical pediatric patients as subjects.

Using available literature and established standards for gastric ultrasound, a 15-minute ultrasound training video course will be designed that gives instruction on ultrasound orientation, use, and the antral scoring system of gastric contents. Ten novice ultrasound users will be selected by study personnel on a volunteer basis from a pool of undergraduate students, medical students, and inexperienced anesthesiologists acting as research interns.

For Part 1, 30 healthy adult volunteers with unknown gastric-content status will be recruited to serve as scanning subjects. For Part 2 (which will only begin after successful completion of Part 1), 30 patients will be recruited from pediatric hospital populations undergoing surgery in the preoperative area or the in- patient unit.

Each novice will assess the gastric contents of 6 subjects (3 in Part 1 and 3 in Part 2) using the clinical algorithm for gastric ultrasound and aspiration risk assessment - giving an antral grade for each subject (a score of 0-2). Each novice ultrasound assessment will be video recorded. In the weeks following this evaluation, expert ultrasonographers will observe each video and give their own scores for each subject using the antral grading system.

Eligibility criteria: Inclusion Criteria:

Patients must:

1. be between ages of 2-60 years of age
2. have parental consent for children 2-17 years of age, or if the participant is 18 years or older, the participant must sign the ICF for them self as an adult
3. undergoing interventional radiology procedures under general anesthesia or located at an inpatient/outpatient facility at LPCH if they are a pediatric patient
4. must be over 18 years of age if a healthy volunteer

Exclusion Criteria:

1. Patients undergoing emergent surgical procedures
2. BMI greater than 24

Primary outcomes:
measure: Novice vs Expert Ultrasonographers Gastric Evaluation
timeFrame: Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.
Secondary outcomes:
measure: Time elapsed to reach gastric evaluation
timeFrame: Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: LPCH/SHC
state: California
Study officials:
affiliation: Stanford University
name: Ban CH Tsui, MD
role: STUDY_DIRECTOR
References:
citation: Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.
citation: Spencer AO, Walker AM, Lardner DR, Perlas A. Reply to Schmitz et al. regarding 'Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes'. Paediatr Anaesth. 2016 Jun;26(6):672-3. doi: 10.1111/pan.12915. No abstract available.
citation: Kruisselbrink R, Arzola C, Endersby R, Tse C, Chan V, Perlas A. Intra- and interrater reliability of ultrasound assessment of gastric volume. Anesthesiology. 2014 Jul;121(1):46-51. doi: 10.1097/ALN.0000000000000193.
citation: Khurana J, Gartner SC, Naik L, Tsui BCH. Ultrasound Identification of Diaphragm by Novices Using ABCDE Technique. Reg Anesth Pain Med. 2018 Feb;43(2):161-165. doi: 10.1097/AAP.0000000000000718.